About Illuminant Surgical

A new way of seeing inside the human body.

Tech description:

Job description:

## **📝 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 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. ## **📝 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. * Support development and review of design requirement specifications, ensuring user needs are traceable to verifiable, measurable requirements. * Manage document control activities for NPD and sustaining projects, including change request initiation, routing, approval, and record disposition. **Risk Management** * Develop, update, and maintain technical content of risk management files in compliance with ISO 14971. * Facilitate cross-functional risk management sessions with engineering, clinical, and regulatory stakeholders at each design phase gate. **Verification & Validation** * Collaborate with R&D, manufacturing, and other cross-functional stakeholders to drive process and test method development, product builds, clinical programs, design transfer, and product launch. * Participate in design verification and validation testing, draft V&V protocols and author final reports documenting results against acceptance criteria. * Support usability validation planning and execution in alignment with IEC 62366. * Identify opportunities for improvement to manufacturing processes and test methods, including redesign of equipment, tools, or fixtures to reduce variability and risk. **Nonconformance & CAPA Investigations** * Investigate complex product quality and compliance issues including device evaluations, CAPAs, nonconformances, audit observations, and product risk assessments, applying engineering principles to analyze results, make recommendations, and produce reports. * Lead structured root cause analysis using 5 Whys, Is/Is Not, fishbone, DMAIC, or equivalent methodologies. * Author NCR/CAPA records and effectiveness checks; ensure timely closure within the QMS. **Audit & Regulatory Support** * Serve as a subject matter expert during internal audits and external regulatory inspections (FDA, notified body) covering design control and risk management topics. * Contribute quality-related technical content to regulatory submissions and support submission package review. * Monitor evolving FDA guidance and flag relevant compliance risks to QA/RA leadership proactively. **Manufacturing & Team Support** * Assign and direct support tasks for manufacturing technicians and inspectors throughout receiving inspection, manufacturing and process validations; provide instruction, training, and feedback to ensure execution quality. * Train, coach, and guide team members on quality engineering principles and routine procedures. * Perform other duties as assigned by leadership. ## **🏅 Your Qualifications** **Education & Experience (one of the following):** * Bachelor’s degree in Engineering or related field and 4+ years of medical device quality engineering experience, or * Master’s or Ph.D. degree or equivalent in Engineering or related field and 2+ years of relevant industry experience **Required Skills & Knowledge:** * Proficiency with MS Office Suite, including Word, Excel, and PowerPoint. * Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills * Working knowledge of 21 CFR Part 820 / QMSR, ISO 13485, and ISO 14971. * Hands-on experience developing design control documentation, risk management files, and DHF records. * Experience writing and executing V&V protocols and final reports. * Proficiency with structured problem-solving methodologies (5 Whys, Is/Is Not, DMAIC, or equivalent). * Strong written and verbal communication skills; capable of producing clear, audit-ready documentation independently. * Ability to manage competing priorities across concurrent projects in a fast-paced environment. * Strict attention to detail and high standards for documentation quality. * Ability to interact professionally across all organizational levels and work effectively in cross-functional teams. What else we look for (preferred): * Experience working in a startup or early-stage medical device company. * Experience with FDA guidance for Software as a Medical Device (SaMD), including IEC 62304 software lifecycle requirements. * Familiarity with FDA cybersecurity guidance for medical devices. * Experience with software V&V, including test strategy for complex software systems, regression testing, and software-specific risk analysis. * Exposure to quality oversight of software development processes: version control practices, release management, software configuration management. * Familiarity with IEC 62366 (usability engineering) and/or IEC 60601 (basic safety). * Exposure to sterile device or packaging standards (ISO 11607). * Experience working in a startup or early-stage medical device company. * Knowledge of statistical techniques relevant to V&V: sample size rationale, AQL sampling, measurement systems analysis. * Experience with electronic QMS platforms and structured document control workflows.

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