Senior Medical Device Safety & Compliance Engineer

Edge Staffing Limited; 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

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.