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Medical Device Compliance Engineer Jobs (NOW HIRING)

HK Recruiting

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 ...

Intellectt INC

Compliance Engineer

Plano, TX · On-site

Job Title: Engineer - Degreed III Location: Plano, TX Duration: 12 Months Job Summary We are ... Experience with medical device compliance testing is highly preferred * Hands-on experience working ...

Hologic Inc.

Lead Compliance Engineer, R&D

Newark, DE

$111K - $174K/yr

Hologic 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 ...

Hologic

Lead Compliance Engineer, R&D

Newark, DE · On-site

$111K - $174K/yr

Hologic 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 ...

Hologic

Lead Compliance Engineer, R&D

Newark, DE · On-site

$111K - $174K/yr

Hologic 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 ...

SharkNinja

Compliance Engineer

Needham, MA

The Product Compliance Engineer will partner with global product developers and certification ... This role includes participation in medical device regulatory pathways alongside our consumer and ...

SharkNinja

Compliance Engineer

Needham, MA · On-site

The Product Compliance Engineer will partner with global product developers and certification ... This role includes participation in medical device regulatory pathways alongside our consumer and ...

MatrixCare

Senior Compliance Engineer

San Diego, CA · On-site

$110K - $152K/yr

The Digital Engineering Product Development organization is looking for a Senior Compliance ... You will be the go-to expert on medical device and cybersecurity regulatory requirements, ensuring ...

ResMed

Senior Compliance Engineer

San Diego, CA · On-site

$110K - $152K/yr

The Digital Engineering Product Development organization is looking for a Senior Compliance ... You will be the go-to expert on medical device and cybersecurity regulatory requirements, ensuring ...

Validation & Engineering Group, Inc

PR

... medical device, or other FDA-regulated industries. * Familiarity with GMP documentation practices, quality systems, investigations, CAPA processes, change controls, and regulated documentation ...

Validation & Engineering Group, Inc

PR

... medical device, or other FDA-regulated industries. * Familiarity with GMP documentation practices, quality systems, investigations, CAPA processes, change controls, and regulated documentation ...

Validation & Engineering Group, Inc

PR

... medical device, or other FDA-regulated industries. * Familiarity with GMP documentation practices, quality systems, investigations, CAPA processes, change controls, and regulated documentation ...

Validation & Engineering Group, Inc

PR

... medical device, or other FDA-regulated industries. * Familiarity with GMP documentation practices, quality systems, investigations, CAPA processes, change controls, and regulated documentation ...

Validation & Engineering Group, Inc

PR

... medical device, or other FDA-regulated industries. * Familiarity with GMP documentation practices, quality systems, investigations, CAPA processes, change controls, and regulated documentation ...

Accuray

Senior Compliance Engineer

Madison, WI · On-site

... medical device environment. REPORTING TO/DEPARTMENT: Reports to the Director, Systems Engineering ... Maintain product compliance with global regulatory and safety standards, including CE Mark and NRTL ...

Kellton Tech

Medical Device Assembler

Madison, WI · On-site

$23 - $24/hr

Ensure work is completed in compliance with company quality system and medical device regulations ... Engineering group as required. Working Conditions: Clean, temperature controlled environment.

A-Line Staffing Solutions

Be Seen First

Medical Device Assembler

Sandy, UT · On-site

$25/hr

Conduct quality inspections and ensure compliance with quality standards and specifications ... Collaborate with engineering and manufacturing teams to support project objectives. * Assist with ...

New

Saxon Global

QA ENGINEER

Saint Augustine, FL

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 ...

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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 Jun 13, 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 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.

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 are Medical Device Compliance Engineers?

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.
More about Medical Device Compliance Engineer jobs
What cities are hiring for Medical Device Compliance Engineer jobs? Cities with the most Medical Device Compliance Engineer job openings:
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What job categories do people searching Medical Device Compliance Engineer jobs look for? The top searched job categories for Medical Device Compliance Engineer jobs are:
Medical Device Compliance Engineer jobs near you
Infographic showing various Medical Device Compliance Engineer job openings in the United States as of June 2026, with employment types broken down into 32% As Needed, 56% Full Time, 3% Part Time, 3% Temporary, 3% Contract, and 3% Nights. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $106,207 per year, or $51.1 per hour.

Lead Compliance Engineer, R&D

HK Recruiting

Newark, DE • On-site

Other

Posted 11 days ago

Job description

Our client is a global leader in medical device innovation, dedicated to improving lives through advanced technology and rigorous quality standards. As we expand our portfolio and reach, we are looking for a talented Lead Compliance Engineer to join our Research & Development (R&D) team and drive product compliance for our global markets.

As the Lead Compliance Engineer, R&D, you will define and execute product compliance strategies, policies, and processes to ensure medical products meet regulatory standards and achieve necessary certifications (e.g., ISO, FCC, UL, IEEE). Serving as the technical subject matter expert, you will work closely with regulatory agencies, participate in product design reviews, and guide cross-functional teams to prevent compliance issues from initial design through production and delivery.

You will oversee both internal and external compliance testing, maintain documentation, and ensure supplier adherence to domestic and international requirements. With your wide-ranging experience, you’ll resolve complex issues, determine new methods and procedures, and may coordinate activities of other personnel as a team lead.

Key Responsibilities:

  • Develop and implement compliance strategies for global regulatory standards (EU MDR, EMC/EMI, safety compliance, etc.) throughout the product lifecycle.
  • Serve as the primary technical expert for regulatory compliance, supporting Program Management, Regulatory Assurance, and R&D teams.
  • Participate in product design reviews, identify applicable regulatory standards, and provide training to prevent compliance issues.
  • Oversee EMC, environmental, and IEC 60601-1 compliance testing at certified labs; act as liaison with agencies such as UL, CSA, TUV, BSI.
  • Drive compliance activities for new product launches, post-launch changes, and corrective actions to ensure ongoing regulatory compliance.
  • Support internal and third-party audits, prepare and review documentation for test labs and regulatory bodies.
  • Create compliance program plans, certification test plans, verification procedures, and reports.
  • Collaborate with engineering, marketing, systems, and manufacturing teams to implement compliance requirements into product definitions.
  • Manage multiple projects and priorities, contributing to CAPA, cost reduction, EOL, and operations support projects.
  • Mentor and train junior engineers as needed.

What we are looking for:

  • Bachelor’s degree required; Master’s or PhD in a technical field strongly preferred.
  • 8+ years of experience (or 6+ years with Master’s, 3+ years with PhD) in compliance testing for product devices and international certifications.
  • Experience with wireless technologies (Wi-Fi, RFID) and electrical test equipment (spectrum analyzers, vector network analyzers, signal generators).
  • Strong understanding of medical device compliance and safety standards, device manufacturing, and product lifecycle processes.
  • Proficient in EMC design concepts, lab test equipment (multi-meters, oscilloscopes, spectrum analyzers, etc.).
  • Ability to troubleshoot and resolve complex EMC issues.
  • Experience leading cross-functional teams and projects.
  • Logical thinking, mature engineering judgement, and strong analytical/problem-solving skills.
  • Effective collaboration and communication skills with technical and non-technical colleagues.
  • Proficiency in revision control and at least one software language (e.g., Python).
  • Familiarity with FDA, FAA, DoD, ISO environments and risk assessment management.
  • Proficient in Microsoft Office Suite (Excel, Word, PowerPoint).
  • Ability to mentor and train junior engineers is a plus.

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