Compliance Engineer (Medical Devices)

TL;DR

Compliance Engineer (Medical Devices): Managing regulatory compliance and product certification for consumer and medical devices with an accent on FDA and EU MDR regulatory pathways. Focus on executing risk management activities, maintaining design controls, and ensuring market access for innovative home healthcare products.

Location: Must be based in Needham, MA, United States

Salary: $72,700–$111,400 USD

Company

A global product design and technology company behind the Shark and Ninja brands, focused on disruptive innovation and AI-native product development.

What you will do

• Support certification activities and risk analysis for new product development, including FDA-regulated medical devices and EU MDR 2017/745 products.
• Prepare regulatory filings such as FDA 510(k) submissions and maintain Design History Files (DHF) per 21 CFR Part 820 and ISO 13485.
• Execute risk management activities per ISO 14971, including hazard identification and residual risk documentation.
• Support usability engineering processes per IEC 62366-1 for home healthcare products.
• Provide subject matter expertise on biocompatibility (ISO 10993), software lifecycle (IEC 62304), and electrical safety (IEC 60601-1-11).
• Participate in weekly project reviews to track certification timelines and regulatory feedback cycles.

Requirements

• Bachelor's degree in Electrical, Mechanical, Biomedical, Systems, Materials Engineering, or Computer Science.
• Minimum 2–4 years of compliance or design-related experience with consumer, commercial, or medical electromechanical products.
• Working knowledge of medical device standards including ISO 14971, ISO 13485, IEC 62366-1, and 21 CFR Part 820.
• Experience with DFMEA and medical-grade risk management documentation.
• Ability to manage multiple projects simultaneously in a fast-paced environment.
• Must be authorized to work in the United States.

Nice to have

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

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401(k) retirement plan with company matching.
• Generous paid time off and company holidays.
• Employee stock purchase program and product discounts.
• Support for personal and professional growth through high-impact learning programs.
• Inclusive environment with a focus on diversity, equity, and inclusion.