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Medical Device Product Engineer Jobs (NOW HIRING)

S. medical device product development. * Deep understanding of the engineering development lifecycle from concept to commercial launch. * Solid knowledge of FDA processes, QMSR, ISO 13485, and design ...

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Medical Device Assembler

San Clemente, CA · On-site

$20.25 - $22.27/hr

Other duties as assigned to support production, engineering, clinical, and QA goals Minimum ... Comfortable working in a regulated environment (medical device experience is a plus) * Ability to ...

Role: R&D Engineer_Human Factors Location: Milpitas, CA - 95035 Duration: 12 Months Shift Timings ... Medical device product development experience * Knowledge of regulatory usability standards and ...

... and test medical device assemblies, final products, and accessories per the manufacturing ... Engineering group as required. Working Conditions: Clean, temperature controlled environment.

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Medical Device Product Engineer information

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$53K

$144.1K

$205K

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

As of Jun 1, 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 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 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 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 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 cities are hiring for Medical Device Product Engineer jobs? Cities with the most Medical Device Product Engineer job openings:
What states have the most Medical Device Product Engineer jobs? States with the most job openings for Medical Device Product Engineer jobs include:
Infographic showing various Medical Device Product Engineer job openings in the United States as of May 2026, with employment types broken down into 25% Full Time, 66% Part Time, 6% Contract, and 3% Nights. Highlights an 93% Physical, and 7% Remote job distribution, with an average salary of $144,072 per year, or $69.3 per hour.

Software Engineer - Medical Device Product Development

Fusion Life Sciences

Newark, DE • On-site

Contractor

Posted 20 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.