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$50K

$97.4K

$150K

How much do medical device developer jobs pay per year?

As of Jun 3, 2026, the average yearly pay for medical device developer in the United States is $97,383.00, according to ZipRecruiter salary data. Most workers in this role earn between $84,000.00 and $107,500.00 per year, depending on experience, location, and employer.

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

To thrive as a Medical Device Developer, you need a strong background in biomedical engineering, product design, and regulatory compliance, typically supported by a relevant degree. Familiarity with CAD software, prototyping tools, and knowledge of FDA or ISO regulatory standards is essential. Creative problem-solving, attention to detail, and effective teamwork are crucial soft skills in this field. These abilities ensure that innovative, safe, and compliant medical devices are developed efficiently to improve patient outcomes.

What are some common challenges Medical Device Developers face when working on new product designs?

Medical Device Developers often encounter challenges related to balancing strict regulatory requirements with innovative design. They must ensure products meet safety and efficacy standards set by agencies like the FDA, while also collaborating closely with cross-functional teams such as engineers, clinicians, and quality assurance. Addressing feedback from clinical trials and adapting to evolving technologies can also add complexity to the development process. Successful developers are adaptable, detail-oriented, and proactive in problem-solving to navigate these hurdles efficiently.

What does a Medical Device Developer do?

A Medical Device Developer is responsible for designing, developing, testing, and refining medical devices such as diagnostic equipment, implants, and monitoring tools. They collaborate with engineers, healthcare professionals, and regulatory bodies to ensure products are safe, effective, and compliant with industry standards. The role involves a combination of research, prototyping, validation, and documentation throughout the product life cycle. Medical Device Developers must stay updated on technological advancements and regulatory changes to create innovative and reliable healthcare solutions.

What is the difference between Medical Device Developer vs Medical Device Engineer?

AspectMedical Device DeveloperMedical Device Engineer
CredentialsTypically requires a degree in biomedical engineering, mechanical engineering, or related fields; certifications like Certified Biomedical Equipment Technician (CBET) are commonSimilar credentials; often holds engineering degrees and may have certifications in medical device design or quality assurance
Work EnvironmentResearch labs, product development teams, manufacturing facilitiesDesign, testing, and quality assurance in labs or manufacturing settings
Industry UsageUsed interchangeably in some companies; focuses on product development lifecycleMore technical focus on engineering aspects, testing, and compliance

While both roles require similar educational backgrounds and work environments, Medical Device Developers often focus on the overall product development process, including design and user needs, whereas Medical Device Engineers concentrate on technical design, testing, and ensuring compliance with standards.

More about Medical Device Developer jobs
What cities are hiring for Medical Device Developer jobs? Cities with the most Medical Device Developer job openings:
What job categories do people searching Medical Device Developer jobs look for? The top searched job categories for Medical Device Developer jobs are:
Medical Device Developer jobs near you
Infographic showing various Medical Device Developer job openings in the United States as of May 2026, with employment types broken down into 10% Full Time, 89% Part Time, and 1% Contract. Highlights an 80% Physical, 5% Hybrid, and 15% Remote job distribution, with an average salary of $97,383 per year, or $46.8 per hour.
Staff Medical Device Autoinjector Engineer

Staff Medical Device Autoinjector Engineer

Thermo Fisher Scientific

Greenville, NC • On-site

Full-time

Retirement

Posted 29 days ago

Thermo Fisher Scientific rating

7.7

Company rating: 7.7 out of 10

Based on 389 frontline employees who took The Breakroom Quiz

186th of 515 rated manufacturers

Job description

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
Job Summary: The Staff Medical Device Engineer will be responsible for developing and maintaining Standard Operating Procedures (SOPs), On-the-Job Training (OJT) documents, and line templates. This role involves ensuring compliance with regulatory standards, optimizing manufacturing processes, and collaborating with vendors. The ideal candidate will have a strong background in pharmaceutical engineering, process improvements, and experience with Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs). We are essentially looking for a device-centric autoinjector subject matter expert.
Key Responsibilities:
Documentation and Compliance:
  • Ensure all documentation is accurate, up-to-date, and accessible to relevant personnel.
  • Compile and create documentation in accordance with relevant regulatory requirements.
  • Manage all post-submission Design History File (DHF) updates in collaboration with Development device teams
  • Support the creation and maintenance of product Design Master Records (DMRs) post-submission

Process Improvement:
  • Identify and implement process improvements to enhance efficiency, quality, and safety in manufacturing operations.
  • Conduct root cause analysis and implement corrective actions for process deviations.
  • Collaborate with cross-functional teams to optimize production processes and reduce waste.
  • Responble for process characterization and defining the specification(s) for the critical process parameters (CPPs) to be used for the device assembly process

FATs/SATs:
  • Participate in Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) to ensure equipment and systems meet specified requirements.
  • Coordinate with vendors and internal teams to address any issues identified during FATs/SATs.
  • Document and report test results, ensuring all acceptance criteria are met.

Vendor Management:
  • Work closely with vendors to ensure timely projects and training for equipment.
  • Detailed design review for the assembly and manufacture of a product

Customers:
  • Support product feasibility assessments.
  • Coordinate all transfer activities from development to operational QC for device testing
  • Manage qualification and validation activities associated with exhibit, submission and commercial launch batch manufacturing
  • Conduct feasibility assessments and determine the manufacturing strategy for device projects with the Steriles technologies

Qualifications:
  • Graduate level degree (Master's) in Pharmaceutical Engineering, Chemical Engineering, Physics, or similar field highly preferred.
  • 8+ years of operations experience in a pharmaceutical manufacturing environment.
  • Experience working with Device vendors and OEMS
  • Strong experience working with Autoinjectors
  • Knowledge of the regulatory requirements for devices and combination products with the US and EU, including the compilation of Design History Files and Design Master records.
  • Knowledge of Device Quality Management Systems in accordance with ISO13485 and 21CFR820
  • Experience of managing Device Development Projects, ideally from concept to launch
  • Understanding of device and drug/device combination regulatory requirements
  • Understanding of device design and assembly including tool development and manufacturing processes
  • Experience with process improvement methodologies (e.g., Lean, Six Sigma).
  • Excellent problem-solving skills and attention to detail.
  • Strong communication and interpersonal skills.
  • Ability to work collaboratively in a team environment.
  • Experience with FATs/SATs and vendor management is highly desirable.

Working Conditions:
  • This position may require occasional travel to vendor sites and manufacturing facilities.
  • Work in a fast-paced, dynamic environment with changing priorities.

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team.

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