At NeuroPace, employees are our greatest asset. We are continually searching for solution-oriented individuals who can bring energy and creativity to our growing workforce. At NeuroPace, our success depends upon our ability to recruit and retain the most talented, enthusiastic and dedicated people we can find and providing them with a dynamic and challenging environment in which to thrive.
NeuroPace is proud to be an equal opportunity employer and values the contributions of our culturally diverse workforce.
NEUROPACE, INC. IS AN EQUAL OPPORTUNITY EMPLOYER AND DOES NOT DISCRIMINATE ON THE BASIS OF RACE, COLOR, RELIGION, GENDER, SEXUAL ORIENTATION, NATIONAL ORIGIN, MARITAL STATUS, PHYSICAL OR MENTAL DISABILITY, MEDICAL CONDITION OR AGE.
The Accounts Payable Assistant supports our accounting team in the payment of goods and services purchased. This person will ensure invoices are accurate and proper accounting procedures are followed for the purchasing and payment of goods and services.
Overall Duties and Responsibilities
Include the following (other duties may be assigned):
- Process invoices in the ERP system
- Communicate with co-workers, management, clients and others regarding purchases
- Resolve pricing and receiving discrepancies by working with multiple departments to find the solution
- Assist with weekly check runs (must come into the office at least one day per week)
Competencies & Requirements
- 2+ years of experience in accounting or bookkeeping
- Experience in Accounts Payable highly desired
- Excellent attention to detail
- Stellar communication skills, both written and oral
- Ability to work effectively as a team
- Strong office computer knowledge is required, applicants must have experience with an ERP system and Excel
Education and/or Experience
High school diploma, Bachelor’s degree is a plus but not required.
The primary focus of this to position to manage the operational activities at selected participating institutions for one or more US‐based IDE pre‐market clinical and post‐market investigations. The responsibilities include, but are not limited to overseeing site evaluation, site initiation, training, study data and regulatory documentation monitoring, and close‐out activities in accordance with the protocol, company standard operating procedures, good clinical practices (GCP), and other applicable regulatory requirements. The successful candidate will function as a key member of the clinical trial team, interacting closely with clinical trial managers, data management, and CRA colleagues. Approximately 80% domestic travel can be expected. This position is based out of the candidate’s home office.
- Conduct site qualification visits to determine adequacy of facilities and staff, patient recruitment and retention potential, ability to comply with regulatory requirements, and overall interest and commitment of principal investigator to conduct and complete the planned clinical study.
- Conduct site initiation visits for the purpose of training site personnel on the protocol, study procedures, patient recruitment and retention requirements, regulatory requirements, case report form completion and retention requirements, adverse events, reporting procedures and overall management.
- Perform or assist in the training of investigators.
- Conduct monitoring visits to review and assure the rights, welfare, and safety of study subjects are protected, and ensure integrity of clinical data with respect to accuracy, accountability, documentation, and adherence to procedures through review of eCRFs, source documents, medical records, and regulatory documents.
- Conduct co‐monitoring visits at investigational sites as needed.
- Compose timely monitoring visit reports.
- Collect, organize, and electronically submit essential clinical documents for the eTMF.
- Escalate issues to the study team in a timely manner.
- Collaborate with data management to ensure query resolution and support data cleaning.
- Support site audits and site audit preparation in anticipation of site inspections.
- Maintain a working knowledge of and assure compliance with the Good Clinical Practices, Federal Regulatory requirements, Risk‐Based Approach to Monitoring, and NeuroPace SOPs
- Perform other related duties incidental to the work described herein.
- Bachelors Degree in relevant life science field required. MS preferred.
- Minimum 5+ years previous experience in a monitoring capacity.
- Clinical research/clinical trial management certification/education preferred.
- Experience managing medical device clinical studies.
- Experience monitoring trials using an electronic data capture system.
- Ability to effectively communicate with professional medical personnel.
- Thorough knowledge of Good Clinical Practice (ISO 14155), 21 CFR part 50, 54, 56, 812 and other applicable regulations
- Strong time management, organization, interpersonal, verbal and written communication skills with a high degree of accuracy and attention to detail.
- Maintain high level of confidentiality in all business‐related interactions.
- Must be able to travel domestically with short notice as required, up to 80%.
The Senior Clinical Trial Manager will report to the Director of Clinical Affairs and Data Management. The principal function of the position is to manage the execution of a portfolio of multicenter investigational device exemption clinical trials. In particular, the role assumes complete responsibility for clinical study planning, development, and launch as well as the execution of day to day study and data management activities. Success in this role is tied to establishing strong internal and external relationships, ensuring the highest integrity of the data collected, and for each study to achieve its intended goals on time and within budget while ensuring transparency and communication across the team and organization.
Study Development and Leadership
- Support the development of clinical study protocols and related regulatory submissions
- Develop and manage study budgets and timelines, including personnel resource estimates
- Manage operational aspects of multiple clinical trials, with competing deadlines, from study start-up through database lock in compliance with ICH/GCP, company SOP, and other regulatory requirements as relevant to the study
- Proactively manage multifunctional clinical study teams to a identify and manage critical path activities, and achieve deliverables within the larger context of corporate goals
- Ensure that team members are appropriately trained on study conduct and company procedures
- Assist in the development of internal SOPs and processes to ensure ongoing study compliance
- Maintain inspection readiness and participate in FDA or other regulatory authority inspections
- Manage study-related vendors, including review of and input on vendor contracts, SOWs, proactive management of issues, and assistance with invoice reconciliation
- Liaise between corporate finance/legal counsel and investigator institution and vendor representatives relative to the establishment of and adherence to contractual agreements
- Establish and maintain strong working relationships with internal and external teams
- Provide frequent study updates to internal teams, including senior management, and external partners
Documentation and Data
- Develop and implement clinical study processes to support study and data management operations
- Ensure development and implementation of applicable study plans (i.e., clinical trial monitoring plan), protocols, amendments, informed consent templates, CRF forms/completion guidelines and site reference guidelines/instructions
- Manage EDC database specifications, eCRF design, clinical database validation, eCRF completion guidelines, and data management and review plans to ensure high data quality and compliance with applicable industry regulations and standards
- Review protocol deviations and data listings to ensure sponsor oversight
- Manage data query, review, cleaning process to minimize data inconsistencies, errors, or omissions
- Work with data management, statisticians and research scientists to optimize the workflow for study endpoint and adhoc dataset creation and data analysis
- Work with data management to ensure timely database locks for all assigned projects
- BS in health sciences or related field with 7+ years relevant industry experience
- 2+ years’ experience managing project team members in a clinical research environment, preferably in the area of medical devices
- Working knowledge of GCP and regulatory compliance guidelines for clinical trials and quality assurance procedures
- Working knowledge of the FDA submission process, preferably for IDE and PMA submissions
- Keen understanding of clinical trial monitoring and data management requirements
- Experience in finance management (budget forecasting, change order management, etc.)
- Demonstrated skills in negotiation, multi-tasking, organization, and problem solving and the ability to work collaboratively and flexibly in a fast-paced environment
- Strong written communication and presentation skills including the use of appropriate medical and scientific terminology
- Experience and confidence in communicating across a diverse group of internal and external team members, including physicians, IRB staff, FDA staff, regulatory affairs, and senior management
- Willingness and ability to occasionally travel
- Proficiency in the use of computer applications such as MS Word, Excel, PowerPoint
- Experience working with EDC, CTMS, and eTMF systems, including system validation efforts
- Exposure or hands on experience with MedDRA and WHODrug coding
- Understating of basic statistical methods
- Experience with enterprise or customer relationship management solutions
- Experience with SQL coding
- Awareness of FDA medical device reporting requirements
The successful candidate will function as a key member of the research and development team, interacting closely with clinical, research and engineering personnel. Responsibilities may include data analysis, machine learning model development and validation, deployment and maintenance of ML/AI models on the software production platform, contributing to training dataset development, error analysis and internal documentation.
- Contribute to the development and analysis of large training datasets
- Machine learning/deep learning model training and testing.
- Error analysis of trained machine learning models.
- Contribute to manuscript development and internal documentation.
- Coursework/experience in signal processing and machine learning.
- Python programming.
- Interested in analyzing large neuroscience datasets.
The Database and Linux Systems Administrator is responsible for the care, feeding, and growth of multiple and varied inter-departmental systems. In addition to ensuring that both databases and operating systems are tuned for maximum efficiency and security, this position will also interact directly with software development in order to support the needs of new and ongoing projects, as well as supporting troubleshooting scenarios in a production environment. The position will be responsible for systems located on-site, will also support cloud-based systems (primarily in AWS) and will support future on-premises to cloud migration efforts.
- Research, assess/test, and perform patching and upgrades on both on-premises and cloud-based assets to ensure all systems are properly configured, fully patched, and operating as designed
- Analyze system performance and system failures
- Curate and maintain SQL databases that store and serve near-real time data
- Recommend and advise solutions relating to database physical structure, functional capabilities, security, back-up, and recovery
- Support troubleshooting and resolution of database issues in both production and development environments
- Support database design discussions and reviews
- Interact with cybersecurity to coordinate and implement security measures to safeguard information against accidental or unauthorized damage, modification or disclosure
- Perform regular backup and restore operations on critical infrastructure; develop and implement appropriate processes for data protection, disaster recovery, and failover procedures
- Build and maintain new systems to handle new design requirements and increases in customer-based demand
- Administer additional servers, providing architecture path as needed
- BS in Computer Science or related field, or equivalent experience
- At least 3 years relevant job experience
- DevOps experience in a cloud-based environment desired, but not required
- 3+ years experience as a Linux System Administrator and/or DBA utilizing technologies specifically with Oracle 10g and above, MySQL, SQL/PLSQL, Postgres, Linux, shell scripts, RMAN, DATAPUMP, etc.
- Expertise with managing and maintaining enterprise-level servers and infrastructure, both on-premises and in the cloud
- Strong knowledge of networking, interconnected, and distributed systems
- Working knowledge of Amazon Web Services
- Experience with scripting and automation tools, e.g. Bash, Python
- Experience with API interaction and design, e.g. REST and GraphQL, a plus
- Experience with containerization technologies, e.g. Docker, a plus
- Strong ability to research and learn new technologies
- Team player who communicates effectively and efficiently
The Director, Commercial Operations will ensure the operational team, infrastructure, processes, and tools exist to enable successful outcomes for our field sales (therapy consultant, field clinical engineer), marketing, customer service, and commercial leadership teams. The successful candidate will bring a strategic vision for how the team they lead will build and manage processes using a digital infrastructure that will simplify and improve the daily interactions with software tools across a distributed cross-functional team. The successful candidate must possess an ability to provide both the strategic direction and tactical expertise to drive technical solutions for managing, analyzing, interpreting, modeling and communicating (internally) the data and insights that will drive our business forward. This role is a member of the Commercial Leadership Team, reports to the VP, Manufacturing & Commercial Operations and will regularly interact and support other senior executives including the VP of Marketing, VP of Sales, and CEO.
- Lead and develop teams with responsibility for customer service, order processing, device tracking, CRM, data analytics and reporting, and sales support including forecasting, quotas, compensation and field inventory management. Provide effective leadership to commercial operations team members.
- Collaborate with Commercial leadership to identify, recommend, and implement critical business process improvements to optimize resources, grow revenue, and enhance operational effectiveness.
- Strong business acumen and comprehensive understanding of medical device commercial processes.
- Lead development of a reporting and business intelligence program that provides data analysis and strategic problem solving to achieve commercial objectives.
- Reduce (or eliminate) low value and redundant work that draws resources from more important efforts.
- Assist with territory planning, account segmentation and data management activities.
- Develop KPIs for patient funnel, conversion rates, and ROI analysis for key commercial programs.
- Develop and implement commercial tools, processes and analytics to accelerate growth and bolster our innovation and digitalization efforts. Continue to focus improvement strategies and plans to maximize productivity, drive operational excellence and achieve/exceed business goals and objectives.
- Support other functional areas with reports and dashboards that assist with business and regulated activities such as device tracking, complaint trending and reporting, inventory management, customer and patient support, development, and clinical study execution.
- Provide expert consultation and project management to all assigned initiatives – Engage relevant stakeholders, objectively assess potential solutions, clearly define project deliverables and timelines, develop communication/change management plans, manage and proactively communicate risks and expectations
- Bachelor’s degree required. MBA a plus.
- Minimum of 8+ years Commercial Ops experience; previous medical device experience preferred.
- Excellent command of business drivers and relevant data sets (e.g. financial, sales & marketing, costs, etc.) and comfort with databases and data analytical tools (e.g. SQL, Tableau, Salesforce, ETLs, etc.)
- Expertise with hands-on data analytics and modeling preferably within the medical device industry.
- Proven ability to interact and effectively communicate with peers, customers, business partners, and executives to present actionable insights and facilitate practical use of reports and dashboards.
- Ability to understand and communicate the business impact of data analysis and recommendations.
- Extensive experience with primary tools used by NeuroPace including Excel, Tableau, and Salesforce.
- Demonstrated analytical rigor and can effectively analyze ambiguous, partial, or limited data sets.
- Must be organized, detail-oriented, and driven with the ability to prioritize multiple competing projects.
- Exceptional communication skills. Able to deliver clear messages to a wide variety of audiences.
- High energy, team oriented, data driven and results focused.
- Strong leadership skills with a demonstrated ability to influence different styles.
Contribute to all phases of design and development of a mixed signal system on an ASIC for the Company’s implantable neurostimulator. This position requires a strong engineering background enabling individual technical contributions at the highest level of quality and technical sophistication in the specified areas of expertise. Areas of expertise needed for this position include the following.
- Implantable hardware system design in collaboration with a cross-departmental team.
- Excellent written and verbal technical communication skills.
- Language-based digital circuit design, simulation, and verification.
- Tool selection, use, and management for digital circuit design, characterization, and verification.
Work with small team on all phases of development through manufacturing and test support. The person who fills this position will have immediate responsibility to move the digital circuit and system development for the ASIC forward. Areas of significant individual contributions include the following.
- Requirements generation and management.
- Evaluate power saving design approaches for the digital circuit design including RTL design, clock tree structure, and low power library use.
- Contribute to the mixed signal system architecture.
- Use and manage tools essential to ASIC and system development.
- Develop Python-based circuit characterization tools.
- Write hardware specifications, RTL, and verification protocols.
- Provide engineering support and analysis to manufacturing as needed.
- Bachelor’s degree in electrical or biomedical (electrical) engineering. Masters degree preferred.
- 5+ years of relevant experience through at least one product development cycle. Medical device experience a plus.
- Mixed signal system design.
- Language-based digital circuit design (Verilog preferred).
- Rapid prototyping with FPGA.
- Strong analog and digital circuit analysis skills.
- Excellent technical writing and documentation skills.
- Excellent technical verbal communication skills.
We are looking for a Director of Product Strategy & Business Partnerships to drive the product roadmap, lead annual strategic planning, and pursue important business partnerships that will help the company achieve its strategic vision. This position reports to the VP of Marketing and will work closely with the Sr. Leadership team, as well as cross-functional partners in product development, product marketing, project management, regulatory, clinical research, and data science.
- Own the product roadmap and define priorities that align with the company’s strategic direction. Identify new product and market opportunities that can drive KPIs such as adoption, engagement, retention, and revenue growth.
- Cultivate a deep understanding of clinician and patient needs through user feedback, market research, competitive/industry trends, and data analyses. Understand how current and proposed products integrate with neurologists’ workflow, augments clinical decision-making, and engages patients in their care.
- Ensure that product managers and R&D teams focus on solving the most important customer/user problems and unmet needs in order to deliver exceptional customer value and business impact.
- Define customer requirements and coordinate cross-functionally with product development, cybersecurity, clinical, regulatory, research, and manufacturing teams to successfully execute the product features from ideation to adoption.
- Manage and lead a growing team, focusing on career growth and impact.
- Track and report on market and competitor dynamics, emerging trends and technologies in neuromodulation, digital health, and the application of AI in healthcare.
- With the Sr. Leadership Team, manage the annual strategic planning process to outline company’s growth strategy, including OUS expansion, emerging therapeutic areas, new product innovation, and partnership opportunities.
- Assess and engage in strategic partnerships that are well-aligned with NeuroPace corporate objectives. Work with key partners to establish mutual goals, success metrics, and achieve project milestones.
- Passion for healthcare, and transforming the lives of people living with epilepsy. This is more than a job for us, it is a mission.
- Bachelors degree required. MBA or other advanced degree strongly preferred
- Medical device experience: 10+ years of increasing leadership in product marketing/ product management. Experience in neuromodulation, digital health, and/or disruptive technologies is preferable.
- Leadership track record: Demonstrated ability to lead diverse, cross-functional teams to accomplish ambitious goals, especially when the path forward is uncharted and trailblazing.
- Strong strategic and analytical skills: Ability to distill multiple pieces of qualitative and quantitative information into meaningful storylines, conclusions and recommendations.
- Results-driven: Focused on provider and patient-centered results, measuring success against carefully determined metrics. Ability to create processes from ambiguous problems to drive execution in the right direction.
- Effective collaboration; Outstanding interpersonal skills including developing relationships at all levels in an organization and effectively managing cross-functional teams that are not in one’s direct authority.
- Startup experience and attitude: Desire to roll up your sleeves, align and coordinate cross-functional teams, and get things done. Be flexible and adaptable in fast-moving environment.
- Technical expert on RNS System functioning and programming.
- Provide high level technical support and troubleshooting to NeuroPace clinical users.
- Work as part of a field team to advance the commercial adoption of NeuroPace products.
- Manage patients through all phases of the clinical process as well as educate them on the features and benefits of NeuroPace products
- Work with customers and Therapy Consultants to implement Patient Education programs at key accounts
- Work with Therapy Consultants to support patient education events including EFA meetings and support groups
- Expert on the NeuroPace marketing messaging; provide support of sales and marketing initiatives and programs.
- Work with clinical investigators and NeuroPace clinical and regulatory personnel to facilitate the conduct of clinical trials in a professional and ethical manner.
- Perform on-site training for physicians and allied health personnel.
- Accurately and clearly present technical material to customers in small and large group settings.
- Insure patient safety to the maximum extent possible by adhering to all applicable regulations, standards and requirements.
- Perform detailed feedback and reporting regarding:
- Product improvement for existing products
- Potential future products or improvements
- Any product issues or problems
- Support and attend medical conferences, regional and national symposia and investigator meetings
- Support in-house personnel (engineering, clinical, manufacturing, and legal, etc.) as requested to achieve company goals.
- Represent the company in a professional manner at all times.
- Be available via mobile phone at all times (nights and weekends included) except when on vacation or at other times when alternate coverage has been arranged.
- BS degree or higher in technical, scientific or health field.
- Demonstrated curiosity about the brain through relevant work experience, coursework and degree programs, research positions or internships.
- Medical device experience is a plus, but not essential.
- Ability to adapt to constantly changing scenarios and work as part of a team.
- Ability to clearly present technical material.
- Advanced user of MS Word, Excel, PowerPoint and the ability to quickly learn new applications.
- Excellent writing skills.
- Must be able to clearly and concisely communicate with patients, physicians and nurses as well as individuals at all levels within the company.
- Physical requirements.
- Ability to maneuver in the operating room environment during sterile surgical procedures.
- Ability to lift 35 lbs.
- Able to travel up to 30%-60% of the time (dependent on geographic coverage area). Requires valid US Driver License and ability to drive to accounts within 200 miles.
Contribute to the design and development of a mixed signal system used in the Company’s implantable neurostimulation device. Perform specification, design, simulation, prototyping, documentation, verification, test support and manufacturing release.
- Make substantial individual technical contributions to development projects for the implantable as well as external equipment.
- Act as the project manager for comprehensive projects.
- Design work including mixed signal systems; language based digital and analog system/circuit design, and board design.
- Prototype development including FPGA development for digital designs, and bread boarding of off the shelf components for analog designs.
- Perform electrical failure analysis and other manufacturing-related tasks as needed.
- Strong digital, analog and system engineering
- Typically requires a BS degree in electrical engineering or a related field with a minimum with 5 + years relevant experience.
- Masters degree is a plus.
- Requires a strong background in mixed signal circuit design.
- Must speak and write clearly and unambiguously.
- Must work well within a strong team environment.
- Verilog experience is a plus.
- ASIC design experience is a plus.
- RF experience is a plus.
- A demonstrated interest in medical applications by course work or job experience is a plus.
We are seeking a highly motivated individual to lead talent acquisition at NeuroPace, Inc. Reporting to the VP of HR, you will manage and implement NeuroPace’s talent acquisition strategy to attract top talent across all functional areas and at all levels to support NeuroPace’s on-going growth and expansion needs. This is a high impact role requiring exceptional partnering skills with demonstrated ability, creativity, and experience in developing, managing and executing a recruiting strategy. The individual needs to be strategic in understanding a lean approach to HR processes while also being hands on and tactical while operating as a content expert. You thrive within fast moving, hands on, environment.
Manage the entire recruitment process for candidates and hiring managers including sourcing, screening, behavioral interviews, offer extension including salary negotiation and decline notifications. The ideal candidate must enjoy the challenges of recruiting, as well as have a proven record of hiring the right candidates for the right positions.
- Design and implement a fully integrated recruitment strategy with an emphasis on talent pipeline to ensure we meet current and future staffing requirements
- Create an effective employer branding strategy and employee value proposition that is aligned with our vision and core values to attract and hire exceptional and diverse talent
- Evaluate current hiring process and introduce best-practices to streamline and enhance the overall candidate experience
- Screen and assess candidates through competency-based screening, ensuring only qualified candidates are referred, that all candidates possess required technical skills and are a cultural fit for the Company
- Track, analyze, and leverage key talent metrics and headcount reporting
- Develop strategy for sourcing passive candidates by utilizing all available tools, including company website, social media, job boards, employee referrals, and recruiting tools
- Coach and train hiring managers on employment and interviewing processes
- Oversee the development and updating of job descriptions with key stakeholders to ensure they are aligned with business needs and regulatory requirements
- Oversee the ATS including recommendations for and facilitation of upgrades and improvements
- Manage the internal referral program and build enthusiasm and support for driving candidate referrals from existing employees
Position Requirements & Experience
- Bachelor’s degree required with at least 7 years of experience recruiting in medical device and high tech environments. A mix of both corporate and agency experience is ideal.
- Proven recruiting experience in a rapidly growing environment implementing a wide range of staffing programs for a diverse group of positions
- Excellent knowledge of LinkedIn, strategies regarding passive candidate sourcing, and recruiting software /applications (ATS)
- Previous HRIS and applicant tracking software required
- Experience with ADP Workforce Now a plus.
- Understanding of employment laws as they pertain to recruiting as well as a general understanding of the HR function (including the importance of confidentiality and discretion)
- Ability to work well cross-functionally and influence across the organization at all levels
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
- Excellent written and verbal communication skills with ability to effectively communicate and partner with all levels of the organization
The Manufacturing Engineer will support the development, documentation, verification, and ongoing manufacturing of products and processes required to produce an implantable neurostimulator and supporting lead systems.
- Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment with an emphasis on DFM; conferring with equipment vendors and soliciting input from operators.
- Develops documents, create/updates drawings, validates and transfers processes to manufacturing. This includes designing and or purchasing, installing and qualifying all necessary tools and equipment.
- Provides manufacturing decision-making information by calculating production, labor, and material costs and estimating future requirements.
- Participate in risk analysis activities including FMEA/FMECA, FTA and HFA of designs and processes.
- Support sustaining manufacturing including the investigation into root cause of manufacturing defects and/or failures and recommendation and implementation of appropriate corrective actions.
- Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
- Perform responsibilities while complying with NeuroPace Quality systems procedures.
- BS degree in mechanical or manufacturing engineering and a minimum of 5-7 years relevant work experience. 3 years experience within the medical device industry is desirable.
- Capable of performing hands on work including the assembly and evaluation of prototypes. Familiar with typical laboratory equipment and tools.
- Individual must be a self-starter with good problem solving and analytical skills, capable of independent work, yet also able and willing to work effectively with others.
- Knowledgeable in DOE/SPC/DFM/Lean Manufacturing tools and methods.
- Must be a proficient solid modeling user (Pro/E or Creo preferred) and proficient in Office PC applications.
- Experience with Packaging, Transit and Aging Validation.
- Experience in the medical device industry and training in GMP and ISO 13485 design control procedures highly desirable.
The Nurse Coordinator’s role is to help provide adults living with drug-resistant epilepsy with improved access to healthcare, and simplify what can often be a complex journey to obtain medical evaluation for advanced epilepsy treatment. The Nurse Coordinator will work closely with patients and their families, healthcare providers and their office staff, local field teams, and insurance providers to provide a more seamless experience for those seeking specialized care at comprehensive epilepsy centers.
You should have diverse patient interaction experience in a healthcare setting. As a Nurse Coordinator, you will be responsible for high-quality patient education via phone, email, and/or web conferencing, and assisting with administrative steps along the road to treatment. The ideal candidate is passionate about being a patient advocate and will help individuals navigate their care journey. You must be well organized, as you will be assisting many different individuals at once.
- Upon completion of product training, provide education via phone on the NeuroPace RNS® System to adults living with drug-resistant focal epilepsy.
- Support up to 150 patients per month within the US, providing compassionate high-quality support as patients navigate the complex epilepsy healthcare environment.
- Respond to patient, provider, and field communications in a timely manner.
- Build and maintain strong relationships with the local field teams, healthcare providers and clinic staff as well as with patients and their care partners.
- Facilitate the epilepsy care journey and help patients develop personal plans to access specialized epilepsy care.
- Use critical thinking and problem solving to support each patient.
- A Nursing degree (RN) is required
- 2 or more years in a clinical setting with demonstrated assessment skills and ability to creatively problem-solve.
- Knowledge of disease management and experienced in care coordination delivered with compassion.
- Strong verbal and written communication skills to describe the product and potential next steps to patients, care partners and professionals, and ability to take good notes.
- Working knowledge of Word, Excel, Microsoft Outlook, and database systems (i.e. Salesforce.)
- Excellent organizational skills and attention to detail
- Occasional US travel ~5% for training and conferences.
- Other duties as assigned.
- Experience working with the epilepsy community
- Spanish language speaking ability
Job Description: The Sr. Project Manager will lead cross functional teams in planning and executing key new products or changes to existing products at NeuroPace. The individual will be a member of the product development organization, and be responsible for planning hardware, software and mechanical products to bring them to fruition within scope, budget and on schedule. The individual will provide training on project management methodology and tools.
- Project manager for the Company’s highest priority projects from inception to closure. Create and maintain comprehensive project plans and schedules
- Translate project statuses into executive dashboard-style reporting
- Proactively communicate project expectations, statuses and metrics to all stakeholders
- Perform project risk management strategies as required and take necessary risk mitigation steps
- Coordinate internal resources for the successful execution of key projects such that they are delivered on time and within scope and budget.
- Establish best (project management) practices including defining a process for project estimation and planning, identification and management of project risks, resource allocation/organizational rollup and project level budgeting.
- Introduction of relevant project management tools to the organization especially for establishing and managing schedules.
- Provide leadership to employees working as project managers in addition to their primary roles at NeuroPace.
- Lead monthly project meetings to update management on the status of projects
- Work cross-functionally with Quality, Regulatory, Manufacturing, Clinical, and Marketing to optimize development processes, and clarify responsibilities.
- Proven track record in Project Management
- BS or higher degree in applicable field; MBA and Engineering degree strongly preferred,
- Certified Project Management Professional (PMP) or equivalent
- Minimum of 6+ years medical device experience preferred
- Experience in managing multiple projects across hardware, software and mechanical areas
- Experience in requirements management and traceability preferred
- Strong organizational, problem-solving, and analytical skills
- Excellent written and verbal communication skills and ability to communicate at all levels within the organization.
- Advanced Microsoft Office Suite skills (Word, Outlook, PowerPoint, Excel, Microsoft Project)
Responsible for Regulatory Affairs support of product development and clinical study projects and submissions for highly technical and complex active implantable medical device systems.
- As a core team member of manufacturing and product development teams, with supervision provides regulatory feedback and guidance throughout the product development cycle, and coordinates team inputs for submissions.
- With supervision, manages regulatory submission projects, including review of documentation, writing and preparing submissions (e.g. PMA Real Time Review Supplements, 30-Day Notices and annual reports; IDE Supplements, 5-Day Notices and annual reports; and internal file documentation).
- With supervision, reviews and approves device labeling, promotional and advertising materials including making recommendations for appropriate changes to ensure compliance.
- Begins to develop and maintain positive relationships with regulatory agency reviewers through oral and written communications regarding clarification and follow‑up of select submissions under review.
- With supervision, reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
- Implements regulatory strategies for new and modified products, and assists with project prioritization.
- Assists with providing Regulatory Affairs training to cross-functional teams.
- Assists with implementation of departmental policy and procedures.
- Bachelor’s degree in a scientific or technical discipline required, advanced degree and Professional certification(s) preferred.
- 5 – 6 years Regulatory Affairs medical device industry experience required; experience with Class III medical devices highly preferred (implantable device experience is a plus).
- Ability to rapidly develop working understanding of highly technical and complex active implantable medical device systems required.
- Strong working knowledge of and experience with FDA regulations required. Experience in preparing PMA and/or IDE Supplements highly preferred and understanding of international regulations (e.g., CE Mark / MDR) preferred.
- Regulatory submission management experience required, including excellent project and time management skills with an attention to detail, the ability to effectively manage multiple projects simultaneously.
- Experience in the preparation of regulatory submissions and documentation required, including highly developed written and oral communication, technical writing and editing skills and proficiency with Microsoft Office and Adobe.
- Demonstrated proficiency at meeting deliverable deadlines required.
- Strong knowledge of product development process and design control, and an excellent grasp of change control and verification and validation requirements.
- Strong research and analytical skills.
- Strong organizational, interpersonal and influencing skills.
The position reports to the Controller and responsibilities will include, but not be limited to the following:
- Key contributor in the preparation of all SEC filings (including 10-Q, 10-K, 8-K, Proxy statements etc.) to ensure compliance with SEC rules and regulations, compliance with U.S. GAAP guidance and consistency across all communications.
- Prepare timelines and meeting materials, and distribute draft filings.
- Ensure complete and accurate supporting documentation of financial and other information used in external reporting, including financial statements, earnings release and supporting information, earnings release scripts and Investor Relations materials.
- Develop and maintain expertise with and control company’s use of SEC reporting application tool, Workiva.
- Assist with or review of the xBRL process.
- Research and draft memos and footnotes of new accounting and disclosure guidance.
- Work directly with external auditors and take significant responsibility for the audit process and requests.
- Manage the SOX implementation process, work with third-party providers as well as process and control owners to develop detailed documentation of processes and controls.
- Assist with the preparation of financial statements including Cash Flow and EPS.
Candidates for this position must have a minimum of 6 years of proven experience which includes at least 4 years of public accounting, preferably Big Four audit experience. Candidates must have proficiency in SOX audits. A CPA is highly preferable. Candidates should also possess the following:
- Must be self-motivated and able to independently research relevant SEC rules and regulations and U.S. GAAP guidance to ensure compliance in our internal and external documents.
- Ability to help develop our public disclosures and monitor ongoing compliance.
- Must have solid SEC and U.S. GAAP technical background and ability to research sophisticated accounting and disclosure requirements.
- Excellent verbal and written communication skills
- Detail oriented, well organized, with the ability to manage a variety of primary duties as well as actively contribute to new projects. Can multi-task in a dynamic environment.
- Ability to deliver top-quality results under tight deadlines.
- Ability to work closely with team members and maintain a positive demeanor and professional image.
- Energy and desire to thrive in a fast-paced organization.
- Bachelor’s degree in accounting required.
The NeuroPace Team has a once-in-a-lifetime opportunity to expand the clinical practice for epilepsy care. The selling approach starts with the clinical team of epileptologists, neurologists, neurosurgeons, and the allied professionals who define the appropriate care for patients who are candidates for device therapy. Further call points include the breadth of economic buyers to patient advocacy groups. This is a unique opportunity to work with world-renowned Epilepsy Centers promoting NeuroPace’s singular RNS® System.
- Set an aggressive sales strategy and sales plan to develop new accounts and to grow existing account business.
- Develop physician champions for product adoption in both new and existing accounts while increasing the user base per generator.
- Drive successful market development activities from planning to end results, with particular efforts to strengthen key referral networks
- Implement a targeted approach to growing the business, including action plans that utilize strategic selling sales methodologies
- Incorporate tactical selling skills through proficiency in selling language that includes consultative or solution-need selling
- Establish excellent relationships with physicians allied health professionals; specifically epileptologists, neurologists and neurosurgeons in the territory.
- Manage effective customer education and training; driving participation in specific company sponsored educational and training programs
- Educate customers on the merits and proper clinical usage of RNS® System through presentations and demonstrations using a wide variety of formats and platforms (e.g., slides, clinical sheets, iPad, manuals etc.).
- Manage patients through all phases of the clinical process, as well as educate them on the features and benefits of NeuroPace products
- Work with customers and Field Clinical Engineers to implement Patient Education Programs at key accounts
- Work with Field Clinical Engineers to support patient education events including EFA Meetings and support groups
- Partner with Field Clinical Engineers to achieve business goals set forth within the territory/district and document quarterly activities utilizing provided business tool(s)
- This includes Caspio for patient pipeline management and Salesforce CRM
- Work in close cooperation with Regional and National Sales Management regarding all aspects of territory performance, including overall sales, customer satisfaction, execution of business plan, and reporting mechanisms.
- Develop relationships with hospital personnel (e.g. through casual conversation, meetings, participation in conferences) to identify key decision makers
Qualified candidates will have the following professional skills for this unique opportunity
- Bachelor of Science or Bachelor of Arts required, advanced degree such as an MBA a strong asset
- Minimum 8 years sales experience within the medical device industry. Experience with Class III implantables highly desired
- Proven track record as a consistent top sales performer, preferably in a neurologic focused industry with active implantables, cranial (ENT) implanted devices, or in sales of imaging/robotics/navigation systems for minimally invasive neurosurgery
- Demonstrated success as an individual performer yet effectively leverage team selling to meet and exceed customer needs
- Proficiency in strategic account planning and written development plans
- Demonstrated success in working collaboratively with corporate contacts such as Field Clinical Engineers and case management teams to aid clinicians in their epilepsy practice
- Consistent performance under corporate Business Conduct and AdvaMed compliance.
- Demonstrated verbal, written communication and presentation skills
- PC and mobile based communication at a professional level, suited for peers, for corporate and for customer contact
- Business analysis and sales tracking skills
- Required travel to customer clinics, hospitals and offsite meetings approximately 70%-80% of the time
- Valid Driver’s License
Physical Job Requirements
- The physical demands of the position require full mobility along with transporting product bags, up to 35 pounds.
Culture & Values
NeuroPace is dedicated to developing, manufacturing and marketing safe and effective medical devices that improve the quality of life for patients with neurological disorders. Company priorities include the development of high quality products focused on customer needs and the maintenance of a work environment where employees are respected and encouraged to excel.
By fostering individual performance, teamwork and the spirit of partnership, we provide both the tools and the environment to help employees excel as individuals as well as team members.
NeuroPace offers a comprehensive package including:
- Pre-IPO stock option plan
- 401(k) plan
- Medical insurance with PPO and HMO options
- Dental insurance
- Vision insurance
- Domestic partner health coverage
- Life insurance
- Long-term disability insurance
- Section 125 flexible benefits program, including Health Care Spending Accounts and Child Care Spending Accounts
- Section 529 college savings plan
- Three weeks paid vacation to start
- Eleven paid holidays
- PTO for sick time and family emergencies
- Other benefits
– Health club membership
– Patent awards program
– Anniversary rewards
– Casual dress – everyday
– Company picnics, parties and barbecues
– Fully stocked kitchen
– and more!