Join Us!

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.

Opportunities

Senior Clinical Trial Manager

Job Description

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.

Responsibilities

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 

Requirements

  • 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

Technical Skills

Required

  • 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

Desired

  • Experience with enterprise or customer relationship management solutions
  • Experience with SQL coding
  • Awareness of FDA medical device reporting requirements

Director of Financial Planning and Analysis

The Director of Financial Planning and Analysis (FP&A) will serve as a key member of the corporate finance team, with ownership of the corporate financial model and leadership in development of the financial narrative for investors, Board of Directors and management.  Responsible for driving reporting and usage of financial and operational KPIs, and providing leadership in planning, reporting, forecasting and alignment between finance and other departments. This position reports directly to the CFO.

Areas of Responsibility

  • Provide leadership and take primary responsibility for developing the company’s annual financial plan
  • Work with leadership to develop, maintain and improve long term financial forecasts
  • Develop, implement and maintain quarterly rolling forecasts, continuously improving accuracy
  • Collaborate with Commercial Operations on revenue analysis and forecasting
  • Report performance against plan to internal stakeholders
  • Collaborate effectively with extended leadership team in all financial planning activities; provide meaningful insights and facilitate alignment
  • Develop best-in-class reporting packages and presentations to Board of Directors and investors, including analysis of key business drivers and creation of financial narrative
  • Develop and maintain externally communicated KPIs, including related research, comparable company analyses, data visualization and reporting
  • Identify and drive process improvements relating to financial planning and reporting including creation of relevant tools and dashboards
  • Perform analysis of gross margin and cost of goods sold including quarterly flux
  • Develop metrics to track department and company performance; identify opportunities, provide recommendations, and collaborate across all levels
  • Develop an understanding of cost accounting in the company’s ERP system; provide high level cost accounting support to operations
  • Support ad hoc projects and system improvements to support company’s growth
  • Ensure compliance with all relevant regulatory requirements and internal accounting and financial reporting policies

Requirements

  • Bachelor’s or master’s degree in Finance or Accounting; minimum 8 years of relevant work experience including financial planning and analysis; CPA a plus
  • Experience with a medical device manufacturing company highly desired
  • Strong experience building financial models and reports for executives, board of directors and investors
  • Excellent problem-solving skills; ability to think independently
  • Excellent written and verbal communications and presentation skills
  • Highly organized, flexible, and easily adapts to change
  • A strong team player who can work effectively with multiple functions within the company
  • Entrepreneurial, self-sufficient
  • Energetic go-getter who thrives on new challenges
  • Demonstrated willingness to roll up your sleeves as necessary to help get things done
  • Excellent Excel, data management and PowerPoint skills
  • Strong proficiency in accounting and corporate finance concepts

Clinical Scientist

Job Description

This position requires strong project management skills, broad comprehension of statistical analyses and data management processes, and effective written and verbal communication skills. The position directs multifaceted activities required to produce clinical study reports for regulatory and scientific purposes, from trial conception through completion.

Responsibilities

  • Clinical Research
    • Identify and assist in qualitative and quantitative analyses of clinical trial data to support clinical study reports and product development.
    • Manage the generation of clinical study reports and other clinical documents.
    • Collaborate with Regulatory Affairs in preparing documents/presentation materials for submission to and/or meetings with regulatory agencies.
    • Provide clinical study findings to physicians as necessary in response to questions received by Medical Affairs or Product Monitoring.
    • Assist in the preparation of abstracts, poster presentations, slides, and manuscripts of clinical study findings.
  • Clinical Trial Development
    • Work with clinical scientists, CMO, and statisticians to establish trial endpoints and statistical methods.
    • Contribute to clinical study protocol development, including performing literature reviews and analyses to provide clinical and scientific evidence to support clinical trial design.
    • Assist trial managers in developing and maintaining investigational plan documents, including risk benefit analyses, data analysis plans, and data management plans.
  • Data Management
    • Lead or assist in developing datasets for research, product development, and clinical trials, including working closely with other clinical scientists, statisticians and programmers.
    • Manage dataset validation to confirm accuracy, including leading or assisting in the development of methods to identify data errors and inconsistencies.
    • Develop and use methods for analyzing and monitoring continuously collected product and clinical data.
    • Work with Oracle databases using SQL.
    • Disseminate pertinent data-related information to appropriate clinical and regulatory team members.
    • Coordinate and execute other assigned project tasks to meet departmental and corporate goals.

Requirements

Required

  • Advanced degree in basic or clinical neuroscience, neurology, neurophysiology, or biomedical engineering. PhD strongly preferred.
  • Minimum of 2+ years of experience conducting research.
  • Experience with cloud databases (e.g., GCP), relational databases (e.g. Oracle), and using APIs for data access.
  • Proven written and verbal communication skills.
  • Good understanding of medical terminology.
  • Energetic, detail-oriented individual with strong organizational skills and excellent analytical ability.
  • Work with minimal supervision in a fast-paced, dynamic environment and be able to meet critical timelines.
  • Work effectively in team environment.

Desirable

  • Experience in clinical data management in a pharmaceutical, biotechnology, medical device or clinical research environment a plus.
  • Working knowledge of FDA, GCP, and ICH regulations specific to clinical study protocols.
  • Biostatistics background with experience in SAS or R.

Sr. Mechanical Development Engineer

Job Description

The Sr. Mechanical Development Engineer will support the mechanical design, development, documentation, verification, and transfer to manufacturing of products and processes required to produce an implantable Neurostimulator System. The individual will also provide support to manufacturing.

Responsibilities

  1. Supports the design and documentation of component and assembly specifications for a neurostimulator system.
  2. Designs, procures and qualifies product assembly and component inspection tooling.
  3. Completes risk analysis activities including design and process FMECAs and FTA of designs and processes.
  4. Performs assembly tolerance analyses to ensure reliable fit of components.
  5. Researches, justifies and applies manufacturing technologies to projects.
  6. Applies DFM/DFX principles to component and assembly designs.
    Works closely with suppliers, operations and other development stakeholders to address DFX issues and drive resolutions.
  7. Identifies and develops suppliers to produce parts and assemblies that meet requirements.
  8. Develops and validates manufacturing processes to defined requirements. Process development includes analysis of process data for capability in meeting defined requirements.  Documents validation protocols and reports.  Designs, procures, installs and qualifies all necessary tools and equipment.
  9. Verifies designs against product and/or design requirements including execution of functional testing and design analyses.
  10. Support manufacturing including the investigation into root cause of manufacturing defects and/or failures and recommendation and implementation of appropriate corrective actions.
  11. Perform responsibilities in compliance with NeuroPace Quality system procedures.

 Requirements

  1. BS degree in mechanical, manufacturing or industrial engineering or similar field, and a minimum of 7 years relevant work experience; preferably in the medical device field.
  2. Knowledgeable in many of the following:
    1. Familiar with design of electro-mechanical systems.
    2. Familiar with typical metal and plastic manufacturing processes.
    3. Familiar with fabricating, joining and molding typical engineering thermoplastics.
    4. Familiar with small component assembly while working under a microscope.
    5. Familiar with metallurgy and metal joining processes, including laser and resistance welding.
  3. Experience in the medical device industry (3years minimum) and training in GMP and ISO 13485 design control procedures.
  4. Proficient with CAD design tools (Creo solid modeling preferred).
  5. Capable of performing hands on work in a laboratory including the assembly and evaluation of prototypes. Familiar with typical laboratory equipment and tools.
  6. Experienced in selecting and working with suppliers to develop custom assemblies.
  7. Individual must be a self-starter with good problem solving and analytical skills, capable of independent work.
  8. Demonstrate effective cooperation and collaboration with multidisciplinary project teams.
  9. Knowledgeable in DOE/SPC/DFM tools and methods.
  10. Proficient in office PC applications, including MS Word, Excel, PowerPoint and Project.

Senior Project Manager

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.

Responsibilities

  • 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.

Requirements

  • 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)

Database and Linux Systems Administrator (On-premises and cloud)

Job Description

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.

Duties

  • 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

Experience

  • 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

Requirements

  • 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

Sr. Manager, Human Resources and Talent Acquisition

Job Description

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.

Responsibilities

  • 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

Applied ML/AI Engineer

Job Description

The successful candidate will function as a key member of the research and development team, interacting closely with clinical, research and engineering personnel. Responsibilities include data analysis, machine learning model development and validation, deployment and maintenance of ML/AI models on the software production platform. They will support ad hoc analyses to address research, clinical, and engineering neuroscience questions, and contribute to new technology development. 

Responsibilities

  • Perform AI/ML model development and validation
  • Maintain on premise deep learning machines
  • Build and maintain machine learning processing pipelines
  • Participate in manual labeling and label validation of large neuroscience datasets
  • Interested in IP development and publishing research in top-tiered journals
  • Work well independently and in teams
  • Work well in fast-paced environments and in the presence of ambiguity
  • Work closely with software and electrical engineering teams

Requirements

  • MS/PhD in CS/EE/BME or any engineering field with focus on Machine Learning and Data Science
  • 2+ years experience
  • Good understanding of machine learning concepts such as clustering, feature selection, dimensionality reduction, classification and regression models
  • Good understanding of data structures and algorithms
  • Experience with training and validating deep learning models (CNNs, RNNs, Attention models)
  • Experience with Tensorflow and Keras, or Pytorch
  • Keen interest to stay up-to-date with latest developments in AI
  • Familiarity with signal processing tools and methods (numpy, scipy)
  • Strong programming skills in Python
  • Database skills (SQL)
  • Familiarity with version control tools
  • Self-starter, able to work with minimal supervision
  • Strong problem-solving skills

Desirable

  • Published ML/AI work in journals
  • Prior experience with GCP or AWS
  • Prior experience working with health datasets

Sr. Customer Service Representative

Job Description

We are seeking a highly motivated individual to support NeuroPace customers who pride themselves in accurate & timely delivery of product & transactional services for sales, patients and health care providers. This individual will have exceptional listening skills, have empathy and be a team player.

Job Responsibilities

  • Provide pricing and delivery information, process orders for shipment through invoicing.
  • Configure new customer accounts, pricing, maintain records and perform related clerical tasks.
  • Accurate data entry to register and update device implant records for the lifetime of each patient and/or device.
  • Collaborate with field team members to follow-up on pending purchase orders.
  • Resolve customer requests, questions and complaints; frequently requiring analysis of situations to determine best use of resources.
  • Coordinate, support, and act as a liaison with Field Team (Therapy Consultants and Field Clinical Engineers) as well as other internal departments:
  • Monitor field trunk inventory: including but not limited to –
    • Initiating and coordinating trunk inventory audits.
    • Facilitating inventory transfers in the field between field team members.
    • Troubleshoot inventory discrepancies and performing applicable transactions.
    • Initiate RGAs and follow-up.
  • Collaborate with supervisor on updating work instructions and departmental procedures.
  • Other miscellaneous duties and special projects as requested/required.osely with software and electrical engineering teams

Experience

  • Minimum 5 years work experience in a customer service environment.
  • High School Diploma (or equivalent) required, AS or higher college degree preferred.
  • Medical device or similar product experience preferred.
  • Must have excellent interpersonal, writing, and verbal communication skills.
  • Ability to multi-task with month-end/quarter-end deadlines while maintaining a high level of accuracy, attention to detail, and customer service.
  • Must have excellent analytical, problem solving, and organizational skills, have a strong teamwork orientation.
  • Must be proficient with SalesForce, Excel, Word and Outlook
  • Working knowledge of ERP systems strongly preferred

Sr. Production Planner/Buyer

Job Description

Responsible for the planning, scheduling, coordinating, purchasing and monitoring of products through the complete production cycle.

Responsibilities

  • Responsible for planning product builds, component purchases and subassemblies to support the manufacturing plan while maintaining target inventory levels.
  • Monitor inventory levels and reorder based on forecast, MRP and/or usage history.
  • Negotiate pricing/deliveries to facilitate cost reduction programs.
  • Be cognizant of current production material constraints, field failures, and customer complaints.
  • Proactively communicate changes in demand to manufacturing.
  • Participate in S&OP meetings.
  • Lead/participate in Master Scheduling meetings.
  • Attend daily production meetings.
  • Purchase material as needed to support schedules.
  • Ensure the accuracy of the item master and vendor lead-time data in the ERP system.
  • Responsible for obtaining quotes and negotiating with suppliers.
  • Work with the Quality department to assure the timely flow of product through QC inspection processes as well as the appropriate disposition of non-conforming materials.
  • Provide input when determining obsolete part numbers.
  • Manage WIP reports.
  • Analyze purchase price variances.
  • Communicate possible product shortages to Customer Service

Requirements

  • Bachelor’s degree in a relevant field preferred
  • Minimum of 5+ years planning experience and 2+ years purchasing experience
  • Previous medical device (4 years or more) strongly preferred.
  • Previous experience purchasing & planning electrical, electro-mechanical and mechanical components
  • Proven ability to negotiate with suppliers
  • Knowledge and experience in the utilization of ERP systems.
  • Experience working within a rigorous quality system environment (ISO 13485, FDA cGMP/QSR).
  • Strong collaboration and teamwork skills.
  • Drive a culture of accountability, attention to detail and strict adherence to Quality Management System.
  • Excellent organizational skills with attention to detail.
  • Strong MS Office skills.
  • APICS certification a plus

Software Quality Engineer

Job Description

Responsible for the planning, scheduling, coordinating, purchasing and monitoring of products through the complete production cycle.

Responsibilities

  1. Effective at applying quality engineering to software development, design changes, and manufacturing. Good team player. Perform the following types of tasks as needed, ensuring compliance with industry standards and regulatory requirements:
    • Support design verification and validation efforts through writing of plans, protocols and reports per project schedules. Support software verification and validation design and technical reviews. Participate on project teams and provide guidance to the team on software quality related activities. Assist with software code reviews and requirements writing when needed.
    • Write and execute software verification protocol and reports. Rewrite verification protocols to make them executable by an uninitiated engineer. When possible, automate software verifications to reduce project timelines and increase software quality. As needed, write and execute non-product Software validation protocols.
    • Participate in risk management activities and assist in the management and maintenance of risk management documentation, such as risk analyses, safety analyses, communication analyses, etc. Facilitate product software risk analyses including cybersecurity risks.
    • Suggest and implement improvements to the Software Development Process to improve efficiency and robustness.
      • Apply usability engineering knowledge during applicable analyses, reviews.
      • Resolve manufacturing software problems, and address non-conformances.
      • Complies with quality system requirements and assesses quality and business processes.
  2. Verify and implement Dell laptop and tablet replacements to support manufacturing.
  3. Participate as a member of the engineering change board, ensuring that released parts and documents are accurate and complete; and ensuring that supporting documentation is adequate. Initiate changes to release V&V and production software, software image changes, new tablets/laptops, etc.
  4. Update and maintain the Software Development SOP, Non-Product Software Validation SOP, and other quality system documents, as needed.
  5. Mentors junior engineers as required.

Requirements

  1. BS degree in a recognized engineering discipline, preferably Software Engineering
  2. 5 years minimum experience as a quality professional in a medical device or related industry
  3. Highly desirable: Applies FDA Quality System Regulations and ISO 13485:2016. Familiarity with Medical Device Regulations, ISO 9001:2015, and knowledge of IEC 62304 is a plus.
  4. Highly desirable: Experience in product manufacturing & development, project management
  5. Preferred: Experience with software test automation tools
  6. Essential: Excellent interpersonal skills, both written and verbal

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.

Benefits

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!