Senior/Principal R&D Sustaining Engineer

Neptune Medical is a venture-backed medical device company based in Silicon Valley, pioneering a new class of GI Endoscopy products utilizing our proprietary Dynamic Rigidization™ technology. Our platform enables thin-walled medical tubes—such as overtubes and catheters—to instantly transition between flexible and rigid states, delivering greater control, safety, and procedural efficiency for clinicians. We have successfully commercialized our first products and are now scaling our portfolio to address a broad range of diagnostic and therapeutic endoscopic procedures. As we enter our next phase of growth, we are building a world-class team to help expand our clinical impact and market leadership.

We are seeking a highly motivated and technically driven candidate to join our GI Pathfinder team and contribute to the advancement of Neptune Medical’s clinical and commercial success. The ideal candidate thrives in a fast-paced, collaborative, venture-backed environment, demonstrates strong ownership and accountability, and brings passion, intensity, and curiosity to solving meaningful clinical challenges

TITLE: Senior/Principal R&D Sustaining Engineer

POSITION SUMMARY: The Senior/Principal Sustaining Engineer is a franchise-critical technical leader responsible for driving the continuous improvement, regulatory compliance, and long-term reliability across the GI Pathfinder commercial product portfolio. This role leads cross-functional initiatives, influencing and aligning Quality, Regulatory, Manufacturing, Supply Chain, and Product teams to execute sustaining programs and continuous improvement initiatives. Through a risk-based, data-driven approach, this position ensures products remain compliant, scalable, and competitive while supporting business growth and market expansion.

ROLES AND RESPONSIBILITIES:

• Lead sustaining engineering programs for released products, driving continuous improvement, risk reduction, and regulatory compliance across the product lifecycle.
• Monitor post-market performance data and field feedback to identify trends, risks, and improvement opportunities.
• Lead technical investigations and resolutions for field complaints, nonconformances, and product performance issues, including root cause, risk assessment, and corrective action strategy.
• Plan and execute verification and validation testing as needed for design, material, and supplier changes; author protocols, reports, and risk documentation
• Partner with Quality and Regulatory teams to prepare and support global submissions, change notifications, and technical documentation.
• Drive shelf-life extensions, labeling expansions, usability updates, and compatibility claims in support of market growth.
• Collaborate with Marketing and Commercial teams to translate market needs into compliant product updates.
• Provide technical leadership for cross-functional sustaining initiatives, influencing without direct authority.
• Communicate project updates and progress to stakeholders, including senior management
• Design and prototype concepts based on feedback from clinicians, field teams, and post-market data
  
  

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related technical discipline; Master’s degree preferred.
• 7 years of experience in medical device R&D or sustaining engineering, including post-market product support and design changes.
• Demonstrated experience leading design changes from problem definition through verification, validation, and regulatory approval.
• Strong background in root cause analysis, risk management, and failure investigation for field and quality issues.
• Hands-on experience developing test methods, executing verification and validation testing, and authoring technical reports.
• Experience with product lifecycle management, change control, and technical documentation in a regulated environment.
• Working knowledge of FDA QSR, ISO 13485, and risk management standards (e.g., ISO 14971).
• Experience supporting or preparing global regulatory submissions and change notifications (e.g., FDA, EU/UK).
• Ability to prototype concepts and test fixtures using basic lab tools, rapid prototyping, or machining techniques.
• Strong project management skills, with the ability to manage multiple sustaining initiatives in parallel.
• Excellent written and verbal communication skills, with the ability to present to cross-functional and senior stakeholders.
• Proven ability to work independently, take ownership, and thrive in a fast-paced, collaborative environment.
  
  

PREFERRED QUALIFICATIONS:

• Ability to work effectively under pressure and manage competing priorities while maintaining strong cross-functional relationships.
• Demonstrated organizational skills and executive-level communication, including representing the company to internal and external partners.
• Ability to balance hands-on technical execution with strategic program leadership.
• Experience thriving in a fast-paced startup environment with the ability to take on diverse responsibilities.
  
  

Neptune Medical is located in Burlingame, CA, near the Millbrae Caltrain and BART station.

The starting annual base salary for this role is between $135,000 to $200,000 depending on experience. The actual base pay is dependent upon many factors, such as: education, training, transferable skills, work experience, business needs, and location. The base pay range is subject to change and may be modified in the future. This role will also be eligible for 401(K) with matching and our company equity vesting plan.

Neptune Medical provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.