Compliance Engineer

Responsibilities

• Support certification activities and risk analysis for new product development projects, including FDA-regulated medical devices and EU MDR products
• Prepare regulatory filings including FDA 510(k) submissions and Technical Files/Design Dossiers
• Maintain Design History Files (DHF) in compliance with 21 CFR Part 820 and ISO 13485
• Execute risk management activities in accordance with ISO 14971
• Support usability engineering processes per IEC 62366-1
• Provide subject matter expertise on biocompatibility (ISO 10993), software lifecycle (IEC 62304), and electrical safety (IEC 60601-1-11)
• Contribute to post-market surveillance and complaint handling processes

Requirements

• Bachelor's degree in Electrical, Mechanical, Biomedical, Systems, or Materials Engineering, or Computer Science
• 2–4 years of compliance or design-related experience with consumer, commercial, or medical electromechanical products
• Working knowledge of medical device standards including IEC 60601, ISO 14971, ISO 13485, and IEC 62366-1
• Experience with DFMEA and medical-grade risk management documentation
• Ability to manage multiple projects simultaneously in a fast-paced environment

Preferred Qualifications

• RAC certification
• Familiarity with international medical device regulations (Health Canada, TGA, ANVISA)
• Experience interfacing with FDA, Notified Bodies, or accredited test laboratories

About the Company

SharkNinja is a global product design and technology company with a diversified portfolio of lifestyle solutions. Powered by the Shark and Ninja brands, the company focuses on bringing disruptive innovation to market across multiple product categories.