Senior Design Assurance Engineer
San Francisco, CAFull-timePosted 2 days agoStill listed today
Most applications go out cold — see where you stand first. No sign-up to start.
You apply on the employer's site, with no Olive account needed.
Watch jobs like this. New roles like this one near San Francisco, CA, by email.
Don't just apply. Show up ready.
Olive works from this exact posting.
At a glance
Olive lists jobs from US employers, including remote roles you can work from the United States.
Requirements
Credentials this posting asks for.
Job overview
Coherence Neuro is seeking a Senior Design Assurance Engineer to support development of implantable neurotechnology for first-in-human studies. The role owns risk management and design control processes, working with engineers, neuroscientists, and suppliers across product development. It focuses on device safety, effectiveness, and submission readiness, including design assurance reviews, verification and validation deliverables, quality-system support, and IDE and PMA submission packages.
Skills & qualifications
Skills
Qualifications
Full job description
Senior Design Assurance Engineer
Job Title: Senior Design Assurance Engineer
Location: San Francisco, CA
Type: Full-Time (on-site)
Click here to apply
Coherence Neuro is a highly interdisciplinary neurotechnology company solving some of the most challenging biological and medical problems that remain unmet. Our goal is to develop technologies that significantly increase the quality and length of life for those with debilitating and deadly cancers in the brain and body. We are backed by the best global venture capital firms, and are scaling our team across multiple sites to bring our products to those who need it as quickly and safely as possible. If you're driven to push the boundaries of engineering and science and want to help build something that genuinely changes lives, we want to hear from you. We value diversity and encourage applicants from all backgrounds to join us in our mission. Learn about our team here!
We are seeking a driven and meticulous Senior Design Assurance Engineer to join the Quality team and play a key role in bringing our novel implantable neurotechnology safely to first-in-human studies. The successful candidate will own the risk management and design control processes that ensure our device is safe, effective, and submission-ready, working closely with engineers, neuroscientists, and suppliers throughout the product development lifecycle.
Key Responsibilities
Develop and maintain design & development files, medical device files, and design control documentation per ISO 13485:2016 and 21 CFR Part 820 (QMSR).
Lead product risk management activities in accordance with ISO 14971, including hazard identification, FMEAs, risk-benefit analysis, residual risk evaluation. Prepare required deliverables and document the risk management outcomes, control measures, residual risks in reports. Maintain risk management file for the life of the device.
Lead Design Assurance reviews of technical documentation with the engineering team, develop test methods and test plans, and prepare design verification and validation test deliverables.
Interpret and apply applicable compliance standards and regulations to develop verification testing plans, establish acceptance criteria, validate test methods and define statistical sampling rationales.
Facilitate and document design reviews, ensuring compliance and end-to-end traceability from user needs and requirements through verified design outputs.
Support maintenance of the QMS, including supplier qualification, change control, document management.
Support the preparation of IDE and PMA submission packages
Required Qualifications and Skills
B.S. in Biomedical, Electrical, Mechanical Engineering, or related engineering discipline. Advanced degree preferred.
5+ years of overall experience in the medical device industry, including at least 3 years in a design assurance, quality engineering, or R&D quality role.
Design assurance experience with Class III or active implantable medical devices.
Working knowledge of medical device design controls, quality system regulations, risk management, and electrical safety standards, including ISO 13485, 21 CFR Part 820, ISO 14971, ISO 14708-1, IEC 62304, IEC 62366-1, and IEC 60601-1.
Experience supporting verification and validation activities for medical device hardware or electromechanical systems.
How this job compares
Set against the 2,845 open Quality Engineer jobs on Olive Jobs, counted November 12, 2026.
- Pay
- This postingNot listed
- California median$107–162K/yr301 salary ranges
- US median$40–46/hr153 hourly ranges
- Openings
- Olive Jobs lists 375 open Quality Engineer jobs in California and 2,845 across the US. 3% of them nationwide are listed as remote or flexible.
- Hiring the most in California
- Apple36 open
- Anduril24 open
- Northrop Grumman16 open
- Experience
- This posting asks for at least 5 years of experience; Quality Engineer postings that state a minimum ask for 5 years at the median (2,307 postings).
- Education
- This posting asks for a bachelor's degree; 1,648 of the 2,845 open Quality Engineer jobs (58%) ask for a bachelor's degree or higher.
Counted across the open, public US postings on Olive Jobs on November 12, 2026. Pay medians are the middle values of the low ends and of the high ends of postings that list both ends of a range in the same cadence (a yearly salary or an hourly rate); a range's midpoint is halfway between its ends. Pay and experience figures resting on fewer than 20 postings are left out.
Prepare for this role
You've read the whole posting — now see how you match it.
