Neptune Medical · 20 hours ago
Senior/Principal R&D Sustaining Engineer
Burlingame, CA
Full-time
Onsite
Senior Level, Lead/Staff
$135K/yr - $200K/yr
7+ years expNeptune Medical is a venture-backed medical device company based in Silicon Valley, pioneering a new class of GI Endoscopy products. They are seeking a highly motivated and technically driven candidate to join their GI Pathfinder team as a Senior/Principal R&D Sustaining Engineer, responsible for driving continuous improvement and regulatory compliance across their product portfolio.
Health CareMedicalMedical DeviceRobotics
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
Qualification
Required
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
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
Benefits
401(K) with matching
Company equity vesting plan
Company
Neptune Medical
Neptune Medical is a medical device company that develops endoscopic and surgical devices.
51-200 employees
H1B Sponsorship
Neptune Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (9)
2023 (1)
2022 (2)
Funding
Current Stage
Late StageTotal Funding
$97M2024-08-15Series D· $97M
2020-05-26Series Unknown
2019-01-01Series Unknown
Leadership Team
Alex Tilson
Founder & CEO
Recent News
Medical Product Outsourcing
2025-04-14
Google Patent
2024-12-04
Google Patent
2024-11-19
Company data provided by crunchbase