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Medical Device Development Engineer information

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$49K

$96.2K

$153.5K

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

As of Aug 21, 2026, the average yearly pay for medical device development engineer in the United States is $96,155.00, according to ZipRecruiter salary data. Most workers in this role earn between $79,500.00 and $106,500.00 per year, depending on experience, location, and employer.

What does a medical device development engineer do?

A Medical Device Development Engineer is responsible for designing, developing, and testing medical devices used in healthcare settings. They work closely with doctors, regulatory agencies, and manufacturing teams to ensure devices are safe, effective, and compliant with regulations. Their tasks often include creating prototypes, running experiments, analyzing data, and preparing documentation for regulatory approval. This role requires a strong background in engineering, biology, or materials science, as well as knowledge of medical industry standards.

What are the key skills and qualifications needed to thrive as a medical device development engineer?

To thrive as a Medical Device Development Engineer, you need a solid background in biomedical, mechanical, or electrical engineering, often with a relevant degree and experience in product development. Familiarity with CAD software, regulatory standards (like ISO 13485 and FDA requirements), and prototyping tools is typically required. Strong problem-solving abilities, attention to detail, and effective teamwork and communication skills help you excel in multidisciplinary environments. These competencies are vital to ensure medical devices are safe, effective, and compliant with industry regulations.

How does a medical device development engineer typically collaborate with cross-functional teams during the product development process?

Medical Device Development Engineers frequently work alongside professionals from regulatory, quality assurance, manufacturing, and clinical teams to bring products from concept to market. This collaboration ensures that devices are designed for manufacturability, meet regulatory requirements, and address user needs. Regular meetings, design reviews, and documentation exchanges are common, making strong communication and teamwork skills essential for success in the role.

What is the difference between Medical Device Development Engineer vs Biomedical Engineer?

AspectMedical Device Development EngineerBiomedical Engineer
CredentialsBachelor's or Master's in Engineering, certifications in medical device regulationsBachelor's or Master's in Biomedical Engineering or related field
Work EnvironmentDesign labs, R&D departments, manufacturing settingsHospitals, research labs, medical device companies
Industry UsageFocuses on designing and developing medical devicesBroader scope including medical equipment, implants, and healthcare technology

Medical Device Development Engineers primarily focus on designing and developing medical devices, working closely with engineering and regulatory teams. Biomedical Engineers have a broader role, often involved in research, testing, and improving medical equipment and healthcare technologies. While both roles require engineering credentials and may work in similar environments, their specific responsibilities and focus areas differ.

More about Medical Device Development Engineer jobs

What states have the most Medical Device Development Engineer jobs?

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

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

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

Medical Device Development Engineer jobs near you
Infographic showing various Medical Device Development Engineer job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 15% Part Time, and 7% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $96,155 per year, or $46.2 per hour.

Medical Device Component Development Engineer

PB consulting

Walnut Hills, OH • On-site

Full-time

Posted 7 days ago

Job description

We are seeking a Medical Device Component Development Engineer to support component development, product lifecycle management, and engineering change activities for regulated medical devices. The ideal candidate will have expertise in design controls, verification & validation, supplier quality, process validation, and regulatory compliance.

Roles and Responsibilities
  • Lead component development and engineering change projects from concept to implementation.
  • Manage project timelines, risks, and cross-functional coordination.
  • Support Design Verification & Validation (V&V), test protocols, and technical documentation.
  • Partner with suppliers on component qualification, DFM reviews, tooling, and process capability.
  • Support manufacturing transfer, IQ/OQ/PQ, pilot builds, and production readiness.
  • Apply Design Controls, PLM, ECO/ECN/ECR, Risk Management, and Quality System requirements.
  • Review engineering drawings, GD&T, specifications, and acceptance criteria.
  • Drive root cause analysis using CAPA, 8D, 5 Whys, and Fishbone methodologies.
  • Communicate project status, risks, and technical recommendations to stakeholders.
Required Qualifications
  • Experience in Medical Device Component Development or Product Development.
  • Strong knowledge of:
    • Product Lifecycle Management (PLM)
    • Design Controls & Engineering Change Management (ECO/ECN/ECR)
    • Design Verification & Validation (V&V)
    • ISO 14971, DFMEA, PFMEA
    • ISO 13485 & FDA 21 CFR Part 820/QMSR
    • Supplier Quality Engineering & Design for Manufacturability (DFM)
    • Process Validation (IQ/OQ/PQ)
    • GD&T and engineering drawings
  • Strong project management, communication, and problem-solving skills.
  • Experience working with cross-functional teams in a regulated medical device environment.
Preferred Skills
  • Medical Device Product Development
  • Supplier Quality & Component Qualification
  • Risk Management & Regulatory Compliance
  • Manufacturing Transfer & Validation
  • Root Cause Analysis (CAPA, 8D)
  • Stakeholder & Project Management

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