Senior Software Quality Assurance Engineer (Remote | Medical Devices)

New Yesterday

Now Hiring: Senior Software Quality Assurance Engineer (Remote | Medical Devices) Location: Fully Remote (U.S.-based) Focus: Neuromodulation for Epilepsy & Sleep Apnea
Are you passionate about improving lives through technology? We're looking for a Senior Software Quality Assurance Engineer to join a mission-driven team working on breakthrough neuromodulation devices that help treat epilepsy and sleep apnea.
This isn't your typical QA role, you won't just be testing software. You'll be deeply involved in product development , helping shape software and firmware from the ground up, ensuring it meets both regulatory standards and real-world needs .
What You'll Be Doing:
Take the lead on software quality in product development teams - from early design all the way to launch.
Own and manage risk documentation and design control processes (IEC 62304, ISO 13485).
Chair the change control board , helping guide decisions around defects and updates during development.
Provide technical input in code reviews and be a go-to person for software/firmware-related investigations.
Collaborate with teams across R&D, Clinical, Regulatory, and Operations - and support during audits as an SME.
What We're Looking For:
6+ years' experience in software or firmware quality in the medical device space.
A strong grasp of IEC 62304 , ISO 13485 , and 21 CFR Part 820 .
A confident communicator who can work cross-functionally and present clearly during audits.
Background in Computer Science , Engineering , or related field.
Experience with implantable medical devices ? That's a big plus!
Why You'll Love It Here:
Work on cutting-edge tech that truly changes lives.
Join a passionate, collaborative team with real impact.
Enjoy the freedom and flexibility of working fully remote .
Make your mark on the development of Class III medical devices.
If you're someone who loves meaningful work, enjoys collaborating across teams, and understands the critical balance between innovation and compliance - let's talk!
Apply
Location:
Trenton

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