Senior Product Safety and Compliance Engineer- Medical Devices
SharkNinja, Needham, MA +1
What you will do
- Own certification activities and risk analysis for multiple new product development projects, including FDA-regulated medical devices and products subject to EU MDR 2017/745.
- Lead preparation of regulatory filings – FDA 510(k) submissions and Technical Files/Design Dossiers — and maintain Design History Files (DHF) in compliance with 21 CFR Part 820 Design Controls and ISO 13485.
- Partner day-to-day with Engineering, Quality, Industrial Design, Supply Chain, and Marketing to align regulatory strategy with program goals, translating complex requirements into actionable guidance for design engineers and product managers.
- Own certification timelines, test lab capacity, sample plans and builds, and certification budgets across simultaneous consumer and regulated-device programs, escalating resource conflicts early.
- Establish project needs and deliverables for product development teams and third-party partners, including Notified Bodies and FDA-accredited testing laboratories.