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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 ...

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 ...

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

... 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 ...

Excel Medical Products

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

Assemble medical devices and components according to engineering drawings, work instructions, and ... Inspect finished assemblies for defects, dimensional accuracy, and compliance with specifications

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.

Excel Medical Products

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

Assemble medical devices and components according to engineering drawings, work instructions, and ... Inspect finished assemblies for defects, dimensional accuracy, and compliance with specifications

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All JobsMedical Device Compliance Engineer Jobs

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 Jul 26, 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 medical device company pays the most?

Medical Device Compliance Engineers working for large, established companies such as Medtronic, Abbott, or Johnson & Johnson tend to earn higher salaries due to their size, market presence, and regulatory complexity. Compensation varies based on experience, location, and certifications like ISO 13485 or FDA regulations, but top-paying companies generally offer competitive salaries and benefits within the industry.

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 does a compliance engineer do?

A compliance engineer ensures that medical devices meet regulatory standards and safety requirements set by agencies such as the FDA or ISO. They develop and review documentation, perform testing, and implement quality systems to maintain compliance throughout the product lifecycle. Strong knowledge of regulations, risk management, and testing tools are essential in this role.

What is medical device compliance?

Medical device compliance refers to adhering to regulations and standards set by authorities such as the FDA or ISO to ensure that medical devices are safe, effective, and meet quality requirements. Compliance involves documentation, testing, risk management, and ongoing quality assurance, which are key responsibilities for a Medical Device Compliance Engineer.

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.

Are healthcare compliance jobs in demand?

Healthcare compliance jobs, including roles like Medical Device Compliance Engineers, are in high demand due to increasing regulatory requirements and the growth of the medical device industry. These positions often require knowledge of standards such as ISO 13485 and FDA regulations, and demand for skilled professionals is expected to remain strong as healthcare technology advances.

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.
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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 July 2026, with employment types broken down into 80% Full Time, and 20% Contract. Highlights an 90% In-person, and 10% Hybrid job distribution, with an average salary of $106,207 per year, or $51.1 per hour.
Medical Device Compliance Specialist

Medical Device Compliance Specialist

Actalent

Libertyville, IL

$35/hr

Contractor

Medical, Dental, Vision, Life, Retirement, PTO

Posted 2 days ago

Job description

Job Title: Medical Device Quality and Compliance Specialist

Job Description

We are seeking a Medical Device Quality and Compliance Specialist experienced in complaint handling, MDR reportability assessments, post-market surveillance, CAPA support, audit readiness, and risk-based documentation.

Responsibilities

  • Handle and assess medical device complaints and MDR reportability.
  • Conduct post-market surveillance activities and support CAPA processes.
  • Ensure audit readiness and maintain risk-based documentation.
  • Collaborate with Quality, Regulatory Affairs, Clinical, R&D, Operations, and business stakeholders.
  • Manage quality-system documentation and eMDR/FDA reporting workflows.
  • Provide regulatory decision rationale and maintain audit-ready records.

Essential Skills

  • Strong expertise in medical device quality assurance and regulatory compliance.
  • Proficiency in technical writing and corrective action plans.
  • Experience with FDA medical device reporting, including 21 CFR Part 803.
  • Ability to handle complaint systems and manage documentation.
Job Type & Location

This is a Contract position based out of Libertyville, IL.

Pay and Benefits

The pay range for this position is $35.00 - $35.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Libertyville,IL.

Application Deadline

This position is anticipated to close on Aug 6, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

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About Actalent

Sourced by ZipRecruiter

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

Company size

5,001 - 10,000 Employees

Headquarters location

Hanover, MD, US

Year founded

1983

Social media

Facebook

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