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Lead Compliance Engineer, R&D

Newark, DE · On-site

Our client is a global leader in medical device innovation, dedicated to improving lives through ... As the Lead Compliance Engineer, R&D, you will define and execute product compliance strategies ...

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Medical Device Compliance Engineer information

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$63.5K

$106.2K

$146.5K

How much do medical device compliance engineer jobs pay per year?

As of Sep 5, 2026, the average yearly pay for medical device compliance engineer in the United States is $106,207.00, according to ZipRecruiter salary data. Most workers in this role earn between $84,000.00 and $124,500.00 per year, depending on experience, location, and employer.

What is a medical device compliance engineer?

Medical Device Compliance Engineers are professionals responsible for ensuring that medical devices meet all regulatory standards and requirements before they reach the market. They work closely with design, manufacturing, and quality assurance teams to develop and implement processes that comply with regulations set by organizations like the FDA, ISO, and other international bodies. Their duties include reviewing technical documentation, conducting risk assessments, and liaising with regulatory agencies to ensure ongoing compliance throughout the product lifecycle.

What are some common challenges faced by medical device compliance engineers during product development?

Medical Device Compliance Engineers often face the challenge of keeping up with evolving international regulatory standards, such as FDA and EU MDR requirements, while ensuring that product development stays on schedule. Balancing thorough documentation and risk management with efficient project timelines can be demanding. Additionally, collaborating with cross-functional teams—like R&D, manufacturing, and quality assurance—requires clear communication to address compliance issues early and avoid costly redesigns. Staying proactive in identifying potential regulatory hurdles is key to success in this role.

What are the key skills and qualifications needed to thrive as a medical device compliance engineer, and why are they important?

To thrive as a Medical Device Compliance Engineer, you need a solid background in engineering, regulatory affairs, and quality assurance, typically supported by a degree in engineering or a related field. Familiarity with standards like ISO 13485, FDA 21 CFR Part 820, and tools such as risk management software and document control systems is essential. Strong attention to detail, problem-solving abilities, and effective communication skills help you interpret regulations and collaborate across teams. These skills ensure that medical devices meet stringent regulatory requirements, safeguarding patient safety and enabling successful product launches.

What is the difference between Medical Device Compliance Engineer vs Quality Assurance Engineer?

AspectMedical Device Compliance EngineerQuality Assurance Engineer
CertificationsISO 13485, FDA regulations, MDRISO 9001, Six Sigma, FDA regulations
Work EnvironmentRegulatory agencies, R&D, manufacturingManufacturing, product testing, process improvement
Industry UsageMedical device companies, regulatory bodiesVarious industries including medical devices, manufacturing

The Medical Device Compliance Engineer focuses on ensuring medical devices meet regulatory standards and compliance requirements, working closely with regulatory agencies. In contrast, the Quality Assurance Engineer emphasizes overall product quality, process improvements, and defect prevention across industries. Both roles require knowledge of industry standards and collaborate to ensure safe, effective products.

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Medical Device Compliance Engineer jobs near you
Infographic showing various Medical Device Compliance Engineer job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution, with an average salary of $106,207 per year, or $51.1 per hour.

Senior Medical Device Compliance Engineer

SharkNinja

Needham, MA

Full-time

Posted 29 days ago

SharkNinja rating

8.2

Company rating: 8.2 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

47th of 161 rated electronics manufacturers

Job description

Senior Medical Device Compliance Engineer 

Needham, MA, United States 

The Senior Medical Device Compliance Engineer is responsible for medical device design control, and post-market compliance across SharkNinja's Medical Devices portfolio. This role is hands-on and central to ensuring medical device products are developed and sustained in compliance with global regulatory requirements-while operating within a fast-paced, consumer electronics development environment. 

In this role, you will hold yourself and cross-functional teams accountable for delivering best-in-class, safe, and effective medical devices that meet customer, business, and regulatory requirements. You will apply best practices and pragmatic, creative problem-solving to support high-speed product development, working closely with Engineering, Product Development, Legal, Program Management, and Quality Engineering, including overseas manufacturing partners. 

Key Responsibilities 

  • Drive design control execution for multiple concurrent medical device NPD programs, ensuring high-quality, audit-ready technical documentation. 
  • Lead and support the creation, review, and approval of Design History Files (DHFs), including design and development plans, requirements, design reviews, risk management files, verification and validation plans and reports, and traceability, ensuring documentation is complete and submission ready. 
  • Translate medical device compliance and regulatory requirements into clear, actionable product and engineering requirements  
  • Ensure risk management activities including hazard analysis, DFMEA, and test planning in alignment with QMS processes. 
  • Support post-market design changes by driving and reviewing ECNs, root cause analysis, risk reassessment, and associated verification/validation and documentation updates. 
  • Serve as a hands-on QMS Compliance leader within cross-functional teams, influencing execution through expertise, collaboration, and clear decision-making in a matrixed environment. 
  • Review supplier qualifications, process validations, and manufacturing documentation from OEMs to ensure compliance with medical device requirements. 
  • Support internal audits, supplier audits, and regulatory inspections  

Qualifications & Experience 

  • Bachelor's or Master's degree in Engineering (Mechanical, Electrical, Biomedical), Quality, or a related technical discipline. 
  • 5+ years of experience in design controls, and post-market sustaining of medical devices  
  • Strong experience supporting electromechanical medical devices, preferably within consumer electronics or high-velocity product development environments. 
  • Deep expertise in design controls and risk management, including ISO 14971, hazard analysis, DFMEA, requirements management, and verification/validation. 
  • Experience supporting post-market design changes, including ECNs, root cause analysis, and lifecycle risk management. 
  • Experience working with overseas contract manufacturers and distributors, including qualification, process validation review, and ongoing compliance oversight. 
  • Working knowledge of biocompatibility, electrical safety, labeling, and component change impact assessments. 
  • Strong communication skills and the ability to operate effectively in a complex, matrixed organization. 
  • Pragmatic, detail-oriented mindset suited to fast-paced, innovative-driven environments. 

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