Senior Product Safety and Compliance Engineer (Medical Devices)

TL;DR

Senior Product Safety and Compliance Engineer (Medical Devices): Leading regulatory compliance and certification for medical and consumer products with an accent on FDA 510(k) submissions, EU MDR, and risk management. Focus on executing risk analysis, maintaining Design History Files, and ensuring adherence to ISO and IEC standards for home healthcare environments.

Location: Needham, MA, United States

Salary: $92,200 - $141,400 USD

Company

hirify.global is a global product design and technology company specializing in disruptive lifestyle solutions through its trusted brands, Shark and Ninja.

What you will do

• Lead certification projects from concept to mass production for FDA-regulated medical devices and products subject to EU MDR 2017/745.
• Prepare regulatory filings including FDA 510(k) submissions and Technical Files, and maintain Design History Files (DHF) per 21 CFR Part 820.
• Execute risk management activities in accordance with ISO 14971, including hazard identification and residual risk documentation.
• Support usability engineering processes per IEC 62366-1 for medical device products intended for home healthcare environments.
• Provide subject matter expertise on biocompatibility (ISO 10993), software lifecycle (IEC 62304), and electrical safety (IEC 60601-1-11).
• Mentor junior team members on both consumer product certification and medical device regulatory frameworks.

Requirements

• Bachelor's degree in Electrical, Mechanical, Biomedical, Systems, Materials Engineering, or Computer Science.
• Minimum 5+ years of compliance or design-related experience with consumer, commercial, or medical electromechanical products.
• Strong working knowledge of IEC 60601, ISO 14971, ISO 13485, IEC 62304, and EU MDR 2017/745.
• Experience with DFMEA and medical-grade risk management documentation.
• Ability to operate in a fast-paced environment with shifting priorities and multiple simultaneous projects.

Culture & Benefits

• Comprehensive health coverage including medical, dental, and vision insurance.
• Financial security via 401(k) retirement plan with matching and employee stock purchase program.
• Health savings accounts (HSA) with company contribution and flexible spending accounts.
• Generous paid time off, company holidays, and parental leave.
• Additional perks such as pet insurance, pre-paid legal insurance, and product discounts.
• An AI-native culture that encourages bold experimentation and continuous growth.