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Medical Device Compliance Jobs (NOW HIRING)

Actalent

Medical Device Engineer

Aurora, CO · Hybrid

$57.69/hr

Support compliance efforts related to EU Medical Device Regulation (EU MDR 2017/745). * Develop technical documentation required for product development and regulatory submissions. * Partner with ...

Excel Medical Products

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

Inspect finished assemblies for defects, dimensional accuracy, and compliance with specifications ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

Excel Medical Products

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

Inspect finished assemblies for defects, dimensional accuracy, and compliance with specifications ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

Excel Medical Products

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

Inspect finished assemblies for defects, dimensional accuracy, and compliance with specifications ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

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. Essential Functions Assemble and test finished and semi-finished medical devices per established ...

AstrixTechnology LLC

Be Seen First

Medical Device Assembler

Santa Rosa, CA · On-site

$20 - $25/hr

Maintain compliance with cleanroom protocols, including daily full gowning requirements in a Class ... Medical device, Petrochemical and Clinical Research.

Belcan

Assembler - Medical Device

Pittsburgh, PA

$18/hr

Assembler - Medical Device Location: Pittsburgh, PA ZIP Code: 15238 Start Date: Right Away Keywords ... Use testing and inspection equipment to verify product compliance. * Maintain accurate production ...

Astrix Inc

Medical Device Assembler

Santa Rosa, CA · On-site

$22 - $26/hr

Pay: $22-26/hour Position Summary The Medical Device Assembly Technician is responsible for ... Maintain compliance with cleanroom protocols, including daily full gowning requirements in a Class ...

VOLT

Medical Device Assembler

Plymouth, MN · On-site

$17.50 - $19.25/hr

Experience as a Medical Device Assembler or Production Assembler ... Strong attention to detail, quality, and compliance standards * Ability to follow written work ...

VOLT

Medical Device Assembler

Irvine, CA · On-site

$18 - $19.75/hr

Follow standard operating procedures (SOPs) to ensure compliance with FDA, GMP, and quality system ... Prior experience as a Medical Device Assembler or Production Assembler preferred. * Previous ...

VOLT

Medical Device Assembler

Irvine, CA · On-site

$18 - $19.67/hr

Follow standard operating procedures (SOPs) to ensure compliance with FDA, GMP, and quality system ... Prior experience as a Medical Device Assembler or Production Assembler preferred. * Previous ...

VOLT

Medical Device Assembler

Carmel, IN · On-site

$20 - $23/hr

Follow standard operating procedures (SOPs) to ensure compliance with FDA, GMP, and quality system ... Prior experience as a Medical Device Assembler or Production Assembler is required * Ability to ...

VOLT

Medical Device Assembler

Portland, OR · On-site

$18 - $20/hr

Come create your career with Volt Volt is immediately hiring a Medical Device Assembler in Portland ... Follow standard operating procedures (SOPs) to ensure compliance with FDA, GMP, and quality system ...

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All JobsMedical Device Compliance Jobs

Medical Device Compliance information

See salary details

$31.5K

$98.9K

$207.5K

How much do medical device compliance jobs pay per year?

As of Aug 9, 2026, the average yearly pay for medical device compliance in the United States is $98,949.00, according to ZipRecruiter salary data. Most workers in this role earn between $61,500.00 and $115,000.00 per year, depending on experience, location, and employer.

What are some common challenges faced in a medical device compliance role, and how can they be addressed?

Professionals in Medical Device Compliance often encounter the challenge of keeping up with rapidly evolving global regulations and standards, such as FDA, ISO 13485, and MDR. This requires continuous education and close collaboration with regulatory affairs, quality assurance, and product development teams to ensure all documentation and processes meet compliance requirements. Effective communication and attention to detail are key, as is proactively participating in internal audits and training sessions. By fostering a culture of compliance and staying current with industry updates, these challenges can be managed successfully.

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

AspectMedical Device ComplianceMedical Device Quality Assurance
CertificationsRegulatory knowledge, such as FDA, ISO 13485Quality management system standards, audits, and inspections
Work EnvironmentRegulatory agencies, compliance departmentsManufacturing facilities, quality departments
Employer & Industry UsageMedical device companies, regulatory bodiesMedical device manufacturers, quality assurance teams

While both roles focus on ensuring medical device safety and effectiveness, Medical Device Compliance primarily involves adhering to regulatory requirements and standards, whereas Medical Device Quality Assurance emphasizes maintaining and improving product quality through testing, audits, and process controls. Both are essential for bringing safe, compliant medical devices to market.

What is medical device compliance?

Medical device compliance refers to the process of ensuring that medical devices meet all regulatory requirements and standards before they are marketed or used. This includes adhering to laws and regulations set by agencies such as the FDA in the United States or the European Medicines Agency in Europe. Compliance covers the entire product lifecycle, including design, manufacturing, labeling, and post-market surveillance, to ensure that devices are safe and effective for patients. Companies must maintain thorough documentation and undergo regular audits to demonstrate ongoing compliance.

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

To excel in Medical Device Compliance, you need a comprehensive understanding of regulatory requirements (such as FDA, ISO 13485), risk management, and quality assurance processes, usually supported by a science or engineering degree. Familiarity with quality management systems (QMS), regulatory submission tools, and certifications like RAC (Regulatory Affairs Certification) are highly valuable. Attention to detail, strong problem-solving abilities, and effective communication skills set top professionals apart in this field. These competencies are crucial for ensuring that medical devices meet legal standards, protecting patient safety, and facilitating successful product approvals.
More about Medical Device Compliance jobs
What cities are hiring for Medical Device Compliance jobs? Cities with the most Medical Device Compliance job openings:
What states have the most Medical Device Compliance jobs? States with the most job openings for Medical Device Compliance jobs include:
What job categories do people searching Medical Device Compliance jobs look for? The top searched job categories for Medical Device Compliance jobs are:
Medical Device Compliance jobs near you
Infographic showing various Medical Device Compliance job openings in the United States as of August 2026, with employment types broken down into 80% Full Time, and 20% Contract. Highlights an 100% In-person job distribution, with an average salary of $98,949 per year, or $47.6 per hour.

Senior Medical Device Compliance Engineer

SharkNinja

Needham, MA • On-site

Full-time

Posted 2 days ago

New

SharkNinja rating

8.2

Company rating: 8.2 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

46th of 156 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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