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.
Responsible for Regulatory Affairs support of product development projects and submissions for highly technical and complex active implantable medical device systems.
- As a core team member of manufacturing and product development teams, provides regulatory feedback and guidance throughout the product development cycle, and coordinates team inputs for submissions.
- Manages and prepares regulatory submissions for clinical investigations and marketing approval as well as internal file documentation with minimal supervision and support.
- Develops and maintains positive relationships with regulatory agency reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow‑up of select submissions under review.
- Reviews, makes recommendations for appropriate changes, and approves design control plans, and product and manufacturing changes.
- Reviews, and approves device labeling, promotional and advertising materials including making recommendations for appropriate changes to ensure compliance.
- Develops and implements regulatory strategies for new and modified devices to assure timely regulatory approval in support of business goals and objectives.
- Provides technical guidance and regulatory training/mentoring to cross-functional teams.
- Develops and implements departmental policy and procedures.
- Establishes project priorities, allocating resources and workload.
- Assists in the development of department objectives in support of business objectives.
- Assists in the preparation of department budgets and resource plans.
- Assists Clinical Affairs with the development of the most effective clinical trial strategies and protocols.
- Bachelor’s degree in a scientific or technical discipline required, advanced degree preferred.
- Substantial Regulatory Affairs medical device industry experience required.
- Ability to rapidly develop working understanding of highly technical and complex active implantable medical device systems required.
- Extensive understanding of and experience with FDA regulations required. PMA experience required. Additionally, understanding of international regulations (e.g., CE Mark / MDR) preferred.
- Proficient knowledge of clinical trial strategy and study design with good working knowledge of statistical methods and data reporting.
- Regulatory project management experience required, including excellent project and time management skills with an attention to detail and the ability to effectively manage multiple projects
- Extensive 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.
- Thorough knowledge of product development process and design control, and an excellent grasp of change control and verification and validation requirements.
- Excellent research and analytical skills.
- Excellent organizational, interpersonal and influencing skills.
This position interacts daily with the Controller, Senior Accountant, Staff Accountant, CFO, and other members of the company. The Accounting Manager will have opportunities to work cross-functionally, manage a team and create processes to keep up with the growth of the company. We are looking for someone who wants to work in a dynamic environment where new challenges and changes are always emerging.
- Oversee and manage the general accounting functions, including, but not limited to: accounts payable, accounts receivable, general ledger, payroll, fixed assets, expense reports and cash management.
- Monthly, quarterly and annual close process; ensure timely, efficient and accurate preparation of financial statements in compliance with GAAP.
- Help with quarterly review and year-end financial audit activities and the annual corporate financial controls audit.
- Support sales compensation administration including detailed review of commission and bonus calculations.
- Work with CFO, Controller and external tax advisors on preparation of federal and state income tax returns; manage other tax requirements including sales, use and property taxes.
- Manage other regulatory filings as applicable including Physician Payments Sunshine Act reporting.
- Improve operation performance by creating efficiencies and improving existing processes.
- Implement internal control framework and company policies.
- Perform ad hoc analysis and projects as requested.
- Bachelors degree with a minimum 7 years experience in general accounting, including at least 2 years in comparable position
- Minimum of two years in public accounting
- CPA preferred
- Medical device experience beneficial
- Strong working knowledge of Microsoft office tools with expert knowledge of Excel
- Experience with ERP accounting systems
- Excellent communication and organizational skills
- Able to work efficiently while maintaining a strong attention to detail
The commercial operations team at NeuroPace is responsible for leading data analytics and managing the commercial team’s data infrastructure such as Salesforce, Tableau, and related sales and customer facing processes. This role is responsible for managing, analyzing, interpreting, modeling and communicating the data that will drive our business forward. This role reports to the Sr. Director, Commercial & Manufacturing Operations.
- Informs the decision-making process to produce improved commercial outcomes
- Provides a fact-base and thoughtful partnership to the commercial leadership and executive team
- Identifies and establishes the right measurement frameworks, key performance indicators (KPIs), and analysis to identify actionable opportunities that can be used to drive business growth
- Understands how to take large amounts of data and interpret / analyze it in ways that drive business insights
- Supports development of customer facing dashboards that communicate the power of NeuroPace data
- Support commercial organization ensuring timeliness, completeness, and report accuracy
- Develop metrics and reports to manage sales pipeline, build revenue, and attain quotas
- Coordinate sales forecasting and planning processes at the direction of and to support the VP of Sales
- Assist in development and management of field team compensation plans and quotas
- Assist with territory planning, account segmentation, and data management activities
- Partner with marketing to calculate and report on patient funnel, conversion rates, and ROI for key commercial programs
- Develop actionable insights from customer data including purchasing habits and trends
- Perform data mining, analytics, and revenue modeling to track progress on key performance indicators and identify opportunities for growth and revenue acceleration
- Develop and manage performance dashboards to capture key metrics to be reviewed with field team leadership to reinforce the right actions and behaviors to drive business results
- 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
- Bachelor’s degree required, MBA a plus
- Minimum of 5+ years previous sales analytics 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, Salesforce, etc.
- Recognized for analytical rigor and has ability to effectively analyze ambiguous, partial, or limited data sets
- Must be organized, detail-oriented, and driven with the ability to prioritize multiple competing projects
- Ability to simply explain complex analytical models to less technical users
The manufacturing operations team at NeuroPace is responsible for all manufacturing efforts to provide reliable, quality product to our customers in support of company objectives. This role is responsible for managing the manufacturing of all NeuroPace products built in the Mountain View, California headquarters. This role manages the onsite manufacturing team including the manufacturing supervisor, manufacturing engineers, and product assemblers. This position reports to the NeuroPace head of Operations.
- Meet manufacturing operations financial targets, key performance indicators (KPIs) and benchmarks including productivity, operating income, revenue, margins, inventory, and growth
- Ensure production goals are achieved and assure production activities are in compliance with applicable GMP, ISO, FDA, OSHA and other company manufacturing and safety guidelines
- Provide leadership to accomplish continuous improvement in quality, cycle time and total cost by advocating and driving the use of process excellence methodologies (six sigma, lean, etc.) within operations
- Develop and motivate a high performing team of both direct and indirect reports driving to achieve a common set of goals to provide high quality product to our customers
- Manage daily production schedule and prioritize manufacturing activities to meet product need dates
- Work closely with operations leadership and materials team to ensure product finished goods inventory target levels are maintained in support of company objectives
- Assign duties and coordinate activities of supervisors and employees; maintain schedules and manpower requirements for assigned areas
- Recruit, hire, train staff, evaluate employee performance, and recommend or initiate promotions, transfers, and disciplinary action
- Interact closely with other functional areas (development, marketing, clinical, quality, etc.) to support new product and process development, design for manufacturing, and design transfer activities
- Plan and manage procedures and budget; make budget recommendations for capital spend and labor
- Maintain and improve ERP work order routing standards (work center, flow, set-up /cycle times)
- Develop working knowledge of manufacturing process flows for all products, including test and inspection.
- Analyze and plan workforce utilization, space requirements workflow and design layouts of equipment and workspace for maximum efficiency
- Bachelor’s degree required
- Minimum of 5+ years previous experience manufacturing medical devices with increasing responsibility, ideally with experience in one or more of the following: laser welding, molding and bonding, automated test, cleaning and packaging. Must be knowledgeable in ESD controls and clean room standards.
- Ability to define and execute quality processes in a low volume, fast paced manufacturing environment
- Demonstrated ability to think strategically, build strong teams, and provide manufacturing leadership
- Proven ability to interact and effectively communicate with peers, business partners and suppliers
- Extensive experience and comfort with manufacturing systems and tools, such as ERP (NeuroPace uses IFS)
- Ability to understand and communicate the business impact of manufacturing improvements
- Must be organized, detail-oriented, and driven with the ability to prioritize multiple competing projects
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!