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Medical Device Product Engineer Jobs (NOW HIRING)

VOLT

Product Engineer

San Antonio, TX · On-site

$37 - $39.40/hr

Become familiar with the medical device development life cycles, manufacturing processes, and ... Work with Manufacturing and other Product Development engineers to ensure that products are ...

VOLT

Medical Device Electronic Assembler

Seattle, WA · On-site

$27 - $31/hr

... engineering and quality assurance teams to implement process improvements and ensure product ... in medical device manufacturing or another regulated manufacturing environment with part ...

Crown Medical, Inc.

Medical Device Rep

Boca Raton, FL · On-site

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... We believe that our proven products and customer focused marketing and sales efforts distinguish us ...

Crown Medical, Inc.

Medical Device Rep

Austin, TX · On-site

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... We believe that our proven products and customer focused marketing and sales efforts distinguish us ...

Crown Medical, Inc.

Medical Device Rep

Sarasota, FL · On-site

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... We believe that our proven products and customer focused marketing and sales efforts distinguish us ...

Crown Medical, Inc.

Medical Device Rep

Carlsbad, CA · On-site

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... We believe that our proven products and customer focused marketing and sales efforts distinguish us ...

Crown Medical, Inc.

Medical Device Rep

Baton Rouge, LA · On-site

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... We believe that our proven products and customer focused marketing and sales efforts distinguish us ...

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Medical Device Product Engineer information

See salary details

$53K

$144.1K

$205K

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

As of Sep 2, 2026, the average yearly pay for medical device product engineer in the United States is $144,072.00, according to ZipRecruiter salary data. Most workers in this role earn between $88,000.00 and $205,000.00 per year, depending on experience, location, and employer.

What does a medical device product engineer do?

A Medical Device Product Engineer is responsible for designing, developing, and improving medical devices used in healthcare settings. They work closely with cross-functional teams to ensure products meet regulatory standards, safety requirements, and user needs. Their duties include creating prototypes, conducting tests, analyzing data, and supporting the manufacturing process. Additionally, they often participate in quality assurance and risk assessment to ensure the final product is safe and effective for patients.

What are typical cross-functional collaborations for a medical device product engineer, and how do they impact project success?

Medical Device Product Engineers regularly collaborate with teams such as Regulatory Affairs, Quality Assurance, Manufacturing, and Clinical Affairs. These collaborations are essential for ensuring that products meet regulatory standards, are manufacturable at scale, and address end-user needs. Effective teamwork helps streamline product development, minimize costly redesigns, and accelerate time-to-market. Building strong communication skills and understanding the priorities of other departments can significantly enhance both project outcomes and your personal growth in the role.

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

To thrive as a Medical Device Product Engineer, you need a solid background in engineering (typically biomedical, mechanical, or electrical), knowledge of medical device regulations, and a relevant degree. Familiarity with CAD software, prototyping tools, and regulatory standards like ISO 13485 or FDA requirements is essential. Strong problem-solving skills, teamwork, and attention to detail help you excel in cross-functional environments and ensure product safety. These competencies ensure the development of innovative, compliant, and reliable medical devices that improve patient outcomes and meet industry standards.

What is the difference between Medical Device Product Engineer vs Mechanical Engineer?

AspectMedical Device Product EngineerMechanical Engineer
Required CredentialsBachelor's in engineering, certifications like RAPS or regulatory trainingBachelor's in mechanical engineering, professional engineer (PE) license often preferred
Work EnvironmentMedical device companies, regulated environments, cross-functional teamsManufacturing, design firms, various industries including automotive and aerospace
Industry UsageHealthcare, medical device manufacturing, FDA complianceMultiple industries, focus on mechanical systems and design

Medical Device Product Engineers focus on designing, developing, and ensuring compliance of medical devices, often working within regulated healthcare environments. Mechanical Engineers have a broader scope, working on mechanical systems across various industries. While both roles require engineering degrees, Medical Device Product Engineers often need knowledge of FDA regulations and medical standards, making their roles more specialized within healthcare.

More about Medical Device Product Engineer jobs

What states have the most Medical Device Product Engineer jobs?

States with the most job openings for Medical Device Product Engineer jobs include:

What job categories do people searching Medical Device Product Engineer jobs look for?

The top searched job categories for Medical Device Product Engineer jobs are:

Medical Device Product Engineer jobs near you
Infographic showing various Medical Device Product 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 $144,072 per year, or $69.3 per hour.

Design Quality Engineer

Prophecy Technologies

Indianapolis, IN • On-site

Full-time

Re-posted 5 days ago

Job description

Role Overview:
The Design Quality Engineer will play a crucial role in supporting quality activities throughout the medical device product development lifecycle. This position requires a strong understanding of Design Control requirements and regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and ISO 14971, ensuring compliance and maintaining Design History File (DHF) documentation and risk management processes.
Key Responsibilities:
  • Support quality activities throughout the product development lifecycle.
  • Review and maintain Design History File (DHF) documentation for compliance with regulatory and quality requirements.
  • Lead and support risk management activities including dFMEA, uFMEA, and PHA updates.
  • Ensure traceability between User Needs, Design Inputs, Risk Controls, Verification, Validation, and Design Outputs.
  • Support Design Verification and Validation planning, execution, and documentation reviews.
  • Review Product Characterization, Product Specification (PSD), and CTQ documents.
  • Participate in design reviews and ensure compliance with Design Control processes.
  • Support Cockpit Cognition DHF Build activities, including documentation organization and traceability linkages.
  • Conduct DHF gap assessments and support remediation activities.
  • Collaborate with R&D, Manufacturing, Regulatory Affairs, and Supplier Quality teams.
  • Support CAPA investigations, root cause analysis, and implementation of corrective actions.
  • Ensure compliance with FDA, ISO 13485, ISO 14971, and internal quality procedures.
  • Support internal audits, customer audits, and regulatory inspections.
  • Drive continuous improvement initiatives related to design quality and risk management processes.

Required Skills:
  • Strong understanding of Medical Device Product Development Process and Design Control requirements.
  • Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable regulatory standards.
  • Strong knowledge of Design Controls and medical device product development.
  • Experience with Design History File (DHF) development, review, and remediation.
  • Hands-on experience with Risk Management activities including: dFMEA, uFMEA, Preliminary Hazard Analysis (PHA).
  • Experience with Design Verification and Validation (V&V).
  • Understanding of User Needs, Design Inputs, Design Outputs, and Traceability requirements.
  • Experience preparing and reviewing: Product Specification Documents (PSD), Product Characterization documents, CTQ (Critical-to-Quality) documents.
  • Experience with CAPA, Nonconformance, and root cause investigations.
  • Familiarity with PLM systems such as Windchill or Teamcenter.
  • Experience with Cockpit Cognition DHF Build and DHF traceability management.
  • Strong documentation, technical writing, and audit support skills.

Qualifications:
  • Strong understanding of Medical Device Product Development Process and Design Control requirements.
  • Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable regulatory standards.

Apply