Product Safety Engineer

Edge Staffing; Boston (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

Edge Staffing Limited is seeking a hands-on Senior Product Safety & Compliance Engineer to support certification, regulatory compliance, and risk management for medical devices and related products in the Greater Boston area.

In this contract role, you will partner with development teams, Quality, and external labs to navigate FDA, EU MDR, ISO 13485, and IEC standards from concept through production, ensuring safe and compliant solutions.

Qualifications

• Bachelor's degree in Engineering required.
• Hands-on experience with design, testing, certification and regulatory submissions from concept to production.
• Knowledge of medical device regulations and standards including IEC 60601-1, ISO 14971, ISO 13485 and FDA 21 CFR Part 820.

Responsibilities

• Lead product certification, regulatory compliance, and risk analysis on new product development projects.
• Support FDA-regulated medical devices, including FDA 510(k) submissions and EU MDR requirements.
• Apply design controls and quality standards such as FDA Part 820 and ISO 13485.
• Perform DFMEA, hazard analysis, and risk mitigation with ISO 14971.
• Drive usability evaluation per IEC 62366-1.
• Coordinate testing labs, samples, budgets, and regulatory partners.
• Collaborate with Engineering, Quality, Industrial Design, Supply Chain, and Marketing.
• Provide guidance on electrical safety, EMC, biocompatibility, and software lifecycle.
• Support post-market surveillance and complaint handling under FDA/EU MDR.
• Lead project reviews and mentor junior engineers.

Skills

Bachelor's degree in Engineering

Electromechanical products

FDA 21 CFR Part 820

ISO 13485

IEC 60601-1

IEC 60601-1-2

IEC 60601-1-11

ISO 14971

IEC 62366-1

IEC 62304

ISO 10993

FDA 510(k)

EU MDR 2017/745

DFMEA

Risk management

Cross-functional communication

Education

Bachelor's degree in Engineering

Job description

Senior Product Safety & Compliance Engineer, Medical Devices

Location: Greater Boston area

Employment Type: Contract, Contract-to-Hire

Work Arrangement: Onsite

About the Opportunity

The team at EDGE has partnered with a client who is seeking a hands-on Product Safety & Compliance Engineer to support product certification, regulatory compliance, and risk management across medical devices, consumer products, and commercial electromechanical products.

This role partners with global product development teams, Quality, and external certification agencies to support new product development from concept through production. The ideal candidate brings an engineering background, practical product development experience, and the ability to navigate safety standards, certification requirements, and regulatory processes while working closely with cross-functional teams.

Key Responsibilities

• Lead product certification, regulatory compliance, and risk analysis across multiple new product development projects.
• Support FDA-regulated medical devices, including FDA 510(k) submissions, EU Medical Device Regulation (MDR) requirements, technical files, design dossiers, and Design History Files (DHF).
• Apply design controls and quality standards, including FDA 21 CFR Part 820 and ISO 13485.
• Conduct risk management activities, including hazard analysis, DFMEA, risk mitigation, and residual risk documentation in accordance with ISO 14971.
• Drive usability engineering and evaluation planning in accordance with IEC 62366-1.
• Coordinate certification schedules, test laboratories, sample builds, budgets, and external certification partners.
• Collaborate with Engineering, Quality, Industrial Design, Supply Chain, and Marketing throughout the product development lifecycle.
• Provide technical guidance on electrical safety, electromagnetic compatibility (EMC), biocompatibility, software lifecycle compliance, and home healthcare devices.
• Support post-market surveillance and complaint handling under applicable FDA and EU MDR requirements.
• Lead project reviews and provide technical guidance to junior engineers on product certification and regulatory compliance.

Required Qualifications

• Bachelor's degree in Engineering, such as Electrical, Mechanical, Biomedical, Systems, Materials, or a related discipline. An engineering degree is required.
• Experience in product design, safety, certification, or compliance involving consumer, commercial, or medical electromechanical products.
• Hands-on experience supporting electromechanical products through design, agency testing, certification, and regulatory submission from concept through production.
• Knowledge of applicable medical device regulations and standards, including:
• IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11
• ISO 14971 and ISO 13485
• IEC 62366-1 and IEC 62304
• ISO 10993
• FDA 21 CFR Part 820 and FDA 510(k)
• EU MDR 2017/745
• Experience with DFMEA, hazard analysis, risk controls, and residual risk documentation.
• Strong project coordination, technical problem-solving, and cross-functional communication skills.

Preferred Qualifications

• Experience working directly with the FDA, Notified Bodies, or accredited testing laboratories.
• Familiarity with international regulatory requirements, including Health Canada, TGA Australia, and ANVISA Brazil.
• Specialized knowledge in biomedical or systems engineering, materials compliance (REACH/RoHS), biocompatibility, or embedded software compliance.
• Regulatory Affairs Certification (RAC).

WE ARE NOT WORKING WITH THIRD PARTY AGENCIES ON ANY