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Medical Device Product Development Engineer Jobs

Alexion Pharmaceuticals

$97K - $146K/yr

Understanding of medical device product development risk management methodologies. Possesses ... Master's, or PhD Degree in Engineering(Mechanical, Biomedical, Chemical or Materials Science and ...

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Medical Device Product Development Engineer information

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$39.5K

$87.9K

$132.5K

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

As of Jul 26, 2026, the average yearly pay for medical device product development engineer in the United States is $87,884.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,000.00 and $100,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Medical Device Product Development Engineer, and why are they important?

To thrive as a Medical Device Product Development Engineer, you need a strong background in biomedical, mechanical, or electrical engineering, along with knowledge of FDA regulations and product development processes. Familiarity with CAD software, prototyping tools, risk management systems, and regulatory standards such as ISO 13485 is typically required. Creativity, problem-solving, and effective teamwork are essential soft skills that drive innovation and ensure project success. These skills and qualifications are crucial for developing safe, effective medical devices that meet strict regulatory requirements and address real-world healthcare needs.

What are some common challenges Medical Device Product Development Engineers face when working on new product designs?

Medical Device Product Development Engineers often navigate strict regulatory requirements and rigorous testing protocols to ensure product safety and compliance. Balancing innovative design with manufacturability and cost constraints can be challenging, as can coordinating input from cross-functional teams such as clinical, regulatory, and manufacturing. Additionally, managing project timelines while accommodating iterative design changes based on feedback or testing results requires strong organizational and communication skills.

What does a Medical Device Product Development Engineer do?

A Medical Device Product Development Engineer is responsible for designing, developing, and testing medical devices to ensure they are safe, effective, and compliant with regulatory standards. They work closely with cross-functional teams, including quality assurance, regulatory affairs, and manufacturing, to take products from concept through to production. Their tasks often include prototyping, risk assessment, documentation, and troubleshooting any issues that arise during the development process. Additionally, they must stay updated on industry standards and regulations to ensure that products meet all necessary requirements for market approval.

What is the difference between Medical Device Product Development Engineer vs Quality Assurance Engineer?

AspectMedical Device Product Development EngineerQuality Assurance Engineer
CredentialsEngineering degree, certifications like PMP or Six Sigma often preferredEngineering or science degree, certifications like CQE or ISO auditor training
Work EnvironmentDesign labs, R&D departments, cross-functional teamsManufacturing facilities, quality control labs, compliance departments
Industry UsageInvolved in designing and developing new medical devicesEnsures products meet quality standards and regulatory requirements

While both roles are essential in the medical device industry, the Medical Device Product Development Engineer focuses on creating and improving devices, whereas the Quality Assurance Engineer ensures these devices meet safety and quality standards. Understanding these differences helps in choosing the right career path or job search focus.

More about Medical Device Product Development Engineer jobs
What cities are hiring for Medical Device Product Development Engineer jobs? Cities with the most Medical Device Product Development Engineer job openings:
What states have the most Medical Device Product Development Engineer jobs? States with the most job openings for Medical Device Product Development Engineer jobs include:
What job categories do people searching Medical Device Product Development Engineer jobs look for? The top searched job categories for Medical Device Product Development Engineer jobs are:
Medical Device Product Development Engineer jobs near you
Infographic showing various Medical Device Product Development Engineer job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 82% Full Time, 15% Part Time, and 2% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $87,884 per year, or $42.3 per hour.
Software Engineer - Medical Device Product Development

Software Engineer - Medical Device Product Development

Fusion Life Sciences

Newark, DE • On-site

Contractor

Posted 14 days ago

Job description

 
Job:Software Engineer – Medical Device Product Development
Location: Newark, DE (Hybrid)
 
Experience: 7+ years
 
Industry Preference: Medical Devices / Regulated Healthcare Products / Embedded or Product Software
Role Summary:
We are seeking a Software Engineer with strong product development experience to support development and maintenance of software systems used in medical device platforms.
The role involves designing, developing, debugging, and maintaining software for both existing and next-generation medical device products, while ensuring compliance with quality and regulatory requirements.The ideal candidate will have experience working in cross-functional engineering environments, supporting the full product software lifecycle from design through
testing and release.
Key Responsibilities:
Product Software Development Design, develop, and maintain software for medical device products and platforms.
Implement new product features and support enhancement of existing systems.
Develop software aligned with product design and system architecture.
Agile Development Work within Agile / Scrum development environments.
Support continuous integration and automated build pipelines.
 
Testing & Debugging
Identify, troubleshoot, and resolve complex software issues.
Support development of software test plans and collaborate with test engineers.
Design Documentation
Create and maintain software requirements, design documentation, and technical specifications.
Ensure documentation supports regulatory and internal compliance requirements.
Cross-Functional Collaboration
Work closely with Design Assurance, Regulatory Affairs, Clinical Affairs, and Quality teams.
Support engineering changes and product improvements.

Product Lifecycle Support
Contribute to development of new products and improvements to existing systems.
Participate in product roadmap discussions and technical design reviews.
Technical Leadership
Provide technical guidance and mentorship to junior engineers.
Support adoption of engineering best practices and quality standards.
Required Qualifications:
5+ years of software development experience in product development environments.
Strong programming skills in C++, C#, .NET, or similar object-oriented languages.
Experience with software architecture, algorithms, and data structures.
Experience debugging and troubleshooting complex systems.
Familiarity with version control systems (Git, SVN, Azure DevOps, etc.).
Strong understanding of software development lifecycle.