Senior Product Safety and Compliance Engineer

Responsibilities

• Lead certification projects from product concept to mass production for medical devices and consumer products
• Execute risk management activities in accordance with ISO 14971
• Support preparation of regulatory filings including FDA 510(k) submissions and Technical Files
• Maintain Design History Files (DHF) in compliance with 21 CFR Part 820 and ISO 13485
• Support usability engineering processes per IEC 62366-1
• Provide subject matter expertise on biocompatibility, software lifecycle, and electrical safety
• Lead weekly project reviews and present status/risks to stakeholders
• Mentor junior team members on regulatory frameworks

Requirements

• Bachelor's degree in Engineering (Electrical, Mechanical, Biomedical, Systems, Materials) or Computer Science
• Minimum 5+ years of compliance or design experience with electromechanical products
• Strong knowledge of ISO 14971, ISO 13485, and IEC 60601-1
• Experience with FDA 510(k) submission processes and EU MDR 2017/745
• Proficiency in risk management documentation and DFMEA
• Ability to manage multiple projects in a fast-paced environment

Preferred Qualifications

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

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.