About the role
đź“ť About the Role
⚠️ Please only apply if you are available for an in-person role in Los Angeles. ⚠️
We are looking for a Quality Engineer/Manager to help bring our surgical navigation system to market and sustain it through its commercial lifecycle.
This role presents the unique opportunity to use your quality engineering skills to make a direct and lasting impact on patient safety and clinical care.
Your first year at Illuminant will involve working in a team of committed clinicians and engineers to help finalize the design history file, complete risk management documentation, and drive design verification and validation activities through regulatory approval. You will work across design controls, ISO 14971 risk management, V&V planning and execution, and CAPA, touching nearly every quality function as we cross the finish line from prototype to cleared device.
Our ideal candidate is energized by the challenge of bringing a novel medical device from late-stage development into the operating room. They are a hands-on quality engineer who takes ownership of deliverables end-to-end and thrives in a fast-paced environment. They are fluent in design controls and know how to build a defensible DHF. They are comfortable sitting with engineers in design reviews, with clinicians in usability sessions, and with auditors during inspections. A background in software quality or SaMD is a meaningful advantage, but what matters most is a candidate who can move fluidly between engineering rigor and regulatory discipline. They are energized by the accelerated growth, deep autonomy, and trajectory-setting impact that comes with joining as an early engineer.
đź“ť What You Will Do
Design Controls
- Develop, update, and maintain design control documentation throughout the product development lifecycle, including design plans, inputs/outputs, traceability matrices, and DHF records, in compliance with 21 CFR Part 820 / QMSR and ISO 13485.
