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Medical Device Compliance Engineer Jobs (NOW HIRING)

Saxon Global

QA ENGINEER

Saint Augustine, FL · On-site

Apex Systems has a long-term contract opening for a Medical Device Quality Engineer / Compliance Engineer with a large manufacturing services organization in St. Petersburg, FL. Client is looking for ...

Marquee Staffing - OC

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Medical Device Packaging (Cleanroom)

Lake Forest, CA · On-site

$20 - $21/hr

... engineering drawings, and inspection procedures. * Maintain compliance with FDA, GMP, EN ISO 13485 ... Medical device manufacturing experience preferred; 2+ years is highly desirable. * Experience in an ...

BEPC INC

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Medical Device Assembler

Temecula, CA · On-site

$19.25 - $23.33/hr

Medical Device Assembler Location: Temecula, CA Employment Type: Full-Time / Contract Pay Rate: $19 ... technology, engineering, manufacturing, and project management. At BEPC, we are driven by ...

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Medical Device Compliance Engineer information

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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 Systems Engineering Compliance Engineer

Accuray Incorporated

Madison, WI • On-site

$105K - $144K/yr

Full-time

Re-posted 17 days ago

Key responsibilities

  • Maintain product compliance with global regulatory and safety standards, including CE Mark and NRTL approvals.

  • Lead submissions, responses, and issue resolution with notified bodies and regulatory agencies.

  • Provide input to system and subsystem requirements to ensure compliance with standards and oversee implementation of safety features.

Job description

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Job Description
SUMMARY
Systems Engineers at Accuray analyze, design, develop and test medical device systems to ensure the integration of hardware, software, reliability, regulatory compliance, and safety requirements. A Systems Engineering Compliance Engineer (or just Compliance Engineer) serves as a contributing member of the Systems Engineering team, specifically responsible for maintaining product compliance with global regulatory and safety standards, such as the IEC 60601 family of standards.
As Senior Compliance Engineer, this position is expected to lead submissions, responses, and issue resolution with notified bodies, including CE Mark and NRTL approvals. They also lead by instituting compliance management best practices and lead others in compliance related activities. This role serves as a bridge between systems engineering and compliance, translating regulatory and safety requirements into system requirements, architecture decisions, risk controls, and verification activities.
REPORTING TO/DEPARTMENT
Reports to the Director, Systems Engineering in the Systems & Applied Science department
ESSENTIAL DUTIES AND RESPONSIBILITIES
Regulatory & Certification Management
  • Maintain product compliance with global regulatory and safety standards, including CE Mark and NRTL approvals.
  • Plan, coordinate, and oversee compliance testing activities with external test labs and certification bodies.
  • Lead submissions, responses, and issue resolution with notified bodies and regulatory agencies.
  • Support regulatory filings and product registrations through technical documentation and compliance justifications.

Design for Compliance & Safety
  • Provide input to system and subsystem requirements to ensure alignment with IEC, EN, UL, and other applicable standards.
  • Evaluate system architectures and design solutions to ensure compliance requirements are appropriately allocated across hardware, software, and subsystems.
  • Oversee implementation of safety features across electrical, mechanical, software, and system-level designs.
  • Own safety-related design aspects including insulation coordination, creepage/clearance, environmental robustness, and user interaction safety.
  • Drive compliance considerations through requirements reviews, design reviews, and architecture reviews.

Risk Management & Systems Engineering
  • Lead risk management activities including FMEA, hazard analysis, and fault tree analysis in accordance with ISO 14971.
  • Translate compliance and risk findings into clear, testable engineering requirements.
  • Ensure traceability between regulatory requirements, risk controls, system requirements, and verification activities.
  • Collaborate with systems engineers to incorporate hazards, risk controls, and compliance requirements into system architecture and verification strategies.

Standards Monitoring & Implementation
  • Monitor changes in global regulatory and safety standards and assess impacts to existing and future products.
  • Develop and execute implementation plans for new or revised standards.
  • Serve as a subject matter expert on medical electrical equipment standards, including the IEC 60601 family.

Cross-Functional Collaboration
  • Partner with Quality, Regulatory, Manufacturing, and Engineering teams to ensure compliant and manufacturable designs.
  • Support internal audits, external inspections, and remediation efforts.
  • Mentor engineers and promote best practices in compliance and systems engineering.

Documentation & Compliance Support
  • Develop and maintain technical documentation required for regulatory submissions and audits.
  • Support investigation and resolution of nonconformances, deviations, and field issues related to safety or compliance.

REQUIRED QUALIFICATIONS
  • Bachelor's degree in electrical engineering, systems engineering, or related field.
  • 7+ years of experience in medical device, healthcare technology, or similarly regulated industries.
  • Demonstrated expertise with IEC 60601-1 and applicable collateral and particular standards.
  • Direct experience obtaining CE Mark and/or NRTL approvals for complex electromechanical systems.

PREFERRED QUALIFICATIONS
  • Advanced degree in electrical engineering, systems engineering, or related field.
  • Experience working within ISO 13485 and FDA Quality System Regulation environments.
  • Familiarity with global regulatory frameworks including EU MDR and FDA submissions.
  • Experience working directly with notified bodies and certification agencies.
  • Experience translating regulatory and safety requirements into engineering requirements and design inputs.
  • Strong knowledge of risk management methodologies including FMEA, hazard analysis, and fault tree analysis.
  • Experience developing or managing system-level requirements, traceability, verification planning, and design reviews.
  • Experience supporting multidisciplinary product development programs.
  • Understanding of embedded systems, firmware interactions, and system architecture principles.
  • Strong troubleshooting, technical writing, and cross-functional communication skills.

WORKING CONDITIONS
  • Indoor Environment: The position takes place indoors, providing a comfortable and climate-controlled workspace.
  • Physical Demands: This role may involve standing or walking for extended periods of time, requires manual dexterity and the ability to handle delicate, high-value equipment. Ability to lift and carry equipment or materials required.
  • Work Schedule: Standard working hours are Monday through Friday; however, evening, weekend or other work outside normal business hours and overtime may be required.
  • Computer Usage: Proficiency with computers, including software applications and communication tools, is essential for tasks and collaboration.
  • Personal Protective Equipment: Must wear appropriate personal protective equipment (PPE) and ahere to safety protocols and cleanliness standards.

To qualify for this position, candidates must be able to furnish proof that they are authorized to work in the country they are applying on a permanent basis without sponsorship.
EEO Statement
At Accuray, our commitment to patient-first outcomes drives an inclusive and collaborative work environment where the best ideas rise to the top - and everyone works to push them further. We value diversity in both the professional and personal backgrounds of our employees, as this variety adds rich energy to every team, every project and every work day. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin - including individuals with disabilities and veterans.

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