Senior Design Assurance Engineer

Coherence Neuro is a fast-growing, venture-backed company pioneering implantable technologies that interface with the human body to address critical unmet medical needs. We're looking for driven individuals who are passionate about pushing the boundaries of engineering and science to solve some of the most complex biological challenges. In this early‑stage environment, we seek versatile team members with a hands‑on approach and a willingness to learn quickly and adapt. We value diversity and encourage applicants from all backgrounds to join us in our mission. We are seeking a driven and meticulous Senior Design Assurance Engineer to join the Product Development team and play a key role in bringing our novel implantable neurotechnology safely to first‑in‑human studies. The successful candidate will contribute to establish and maintain the quality and design control systems 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). Work closely with the engineering team to author and review design inputs, design outputs, verification and validation protocols and reports. Interpret and apply applicable standards and regulations to develop verification testing plans and establish acceptance criteria. Facilitate and document design reviews, ensuring compliance and end‑to‑end traceability from user needs and requirements through verified design outputs. Lead product risk management activities in accordance with ISO 14971, including hazard identification, FMEAs, risk‑benefit analysis, residual risk evaluation, etc. Support maintenance of the QMS, including supplier qualification, change control, document management, etc. 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. 4+ years of overall experience in the medical device industry, including at least 2 years in a design assurance, quality engineering, or R&D quality role. Working knowledge of medical device design controls, quality system regulations, risk management, and electrical safety standards, including ISO 13485:2016, 21 CFR Part 820, ISO 14971, and IEC 60601-1. Experience supporting verification and validation activities for medical device hardware or electromechanical systems. Strong attention to detail, technical writing skills, and ability to work cross‑functionally with engineering, quality, regulatory, external suppliers and R&D teams across multiple sites, including support for product development activities at our UK site. Bonus Skills Design assurance experience with active implantable medical devices. Working knowledge of ISO 14708-1:2014. Experience supporting IDE applications, PMA submissions, or early feasibility clinical submissions. Experience in early‑stage or startup environments. Reporting Structure This role is an integral part of the Product Development team and reports to Quality & Regulatory/VP of Engineering. Benefits Healthcare, dental and vision 401k with company match Industry‑leading paid time off (PTO) – 20 days/year + holidays Meals and snacks provided Professional development support and training opportunities. Flexible working hours and travel opportunities (We have sites in Australia, UK and US!) A chance to work on impactful, life‑changing technologies in a dynamic, innovative environment. #J-18808-Ljbffr