This range is provided by Nervonik, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$150,000.00/yr - $300,000.00/yr
Nervonik is a medical technology company dedicated to revolutionizing peripheral nerve stimulation (PNS) for the treatment of chronic pain. Our mission is to develop cutting-edge, minimally invasive solutions that improve patient outcomes and enhance quality of life.
Position Overview
The Senior Director of Engineering will be responsible for leading the technical strategy, research, development, and commercialization of Nervonik’s PNS technology. This leadership role requires expertise in medical device development, neurostimulation systems, and regulatory compliance. The ideal candidate will be a strategic thinker, hands-on problem solver, and effective leader with a passion for advancing neurostimulation therapies.
Key Responsibilities
Technical Leadership & Product Development
- Lead the design, development, and testing of PNS devices, ensuring compliance with FDA, ISO 13485, ISO 14708, IEC 60601, IEC 62366, and ISO 62304 standards.
- Oversee mechanical, electrical, firmware, and software development for the implantable and external neurostimulation systems. Incorporate risk analysis early in the process.
- Drive innovation in lead design, stimulation algorithms, user experience, and bioelectronic interfaces.
- Collaborate with clinical, quality, and regulatory teams to advance product pipelines from concept to commercialization. Prioritize features into multiple product releases.
- Plan and execute usability studies.
Team Leadership & Cross-Functional Collaboration
- Build and lead a multidisciplinary engineering team, including electrical, mechanical, biomedical, and software engineers.
- Work closely with neuroscientists, clinicians, and regulatory experts to translate clinical and compliance needs into engineering solutions.
- Foster a culture of innovation, collaboration, and continuous improvement within the engineering team.
Regulatory & Compliance Oversight
- Ensure all engineering processes comply with FDA QSR, ISO 13485, ISO 14708, IEC 60601, IEC 62366, ISO 62304 and other applicable medical device regulations.
- Support preclinical and clinical trials, including device validation.
- Prepare technical documentation for regulatory submissions (510(k), IDE, PMA, etc.).
Strategic Planning & Execution
- Define and execute the technology roadmap for Nervonik’s PNS products.
- Evaluate emerging neurostimulation technologies and competitive landscapes to maintain technological leadership.
- Drive intellectual property (IP) strategy by identifying patent opportunities and working with legal teams on filings.
- Collaborate with manufacturing partners and suppliers to optimize scalability, cost-effectiveness, and quality controls.
- Drive technical manufacturing documentation for regulatory submissions.
- Provide technical support for market launch and post-market surveillance of PNS devices.
Qualifications & Experience
Required:
- BS, MS, or PhD, degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or a related field.
- 15+ years of experience in medical device development, with at least 10 years in a leadership role.
- Strong expertise in peripheral nerve stimulation (PNS), neurostimulation, or implantable medical devices.
- Proven track record in developing and commercializing Class II or Class III medical devices.
- Deep knowledge of FDA, ISO 14708, IEC 60601, cybersecurity, and other regulatory frameworks.
- Experience leading multidisciplinary teams in a fast-paced R&D environment.
- Hands-on experience with biocompatible materials, electronics design, and neurostimulation systems.
- Experience with wireless communication technologies (Bluetooth, NFC) in medical devices.
- Strong analytical, problem-solving, and project management skills.
Preferred:
- Knowledge of signal processing, bioelectronic therapies, and closed-loop stimulation algorithms.
- Familiarity with machine learning applications in neurostimulation therapy.
- Familiarity with wearable body worn devices and consumables.
- Experience with customer support and field work.
- Experience with fundraising, grant applications, or government-sponsored research initiatives.
How to Apply:
If you are passionate about driving innovation in neurostimulation and medical device engineering, we want to hear from you! Please submit your resume and a cover letter outlining your experience and vision for advancing PNS technology at Nervonik.
Send your application to hr@nervonik.com
Seniority level
Director
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Medical Equipment Manufacturing