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Medical Device Design Engineer Jobs (NOW HIRING)

ICU Medical

Engineer III, Product Design

Southington, CT · On-site

$131K - $157K/yr

Position Summary The Engineer III, Product Design position in the Vascular Access Product ... As a subject matter expert (SME) in medical device development, this position will drive key ...

ICU Medical

Engineer III, Product Design

Southington, CT

$131K - $157K/yr

Position Summary The Engineer III, Product Design position in the Vascular Access Product ... As a subject matter expert (SME) in medical device development, this position will drive key ...

Alcon

Principal Engineer Device Design

Fort Worth, TX · On-site

Alcon is looking to hire a Principal Engineer Device Design team member. This role is part of Alcon ... Applies knowledge of materials and manufacturing methods for medical devices * Generate detailed ...

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Medical Device Design Engineer information

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How much do medical device design engineer jobs pay per hour?

As of Sep 9, 2026, the average hourly pay for medical device design engineer in the United States is $49.84, according to ZipRecruiter salary data. Most workers in this role earn between $35.10 and $59.62 per hour, depending on experience, location, and employer.

What does a medical device design engineer do?

A Medical Device Design Engineer is responsible for designing and developing medical devices that improve patient care and meet regulatory standards. They work on creating prototypes, testing designs, and ensuring products are safe, effective, and manufacturable. Their role often involves collaborating with healthcare professionals, regulatory specialists, and manufacturing teams. They also stay up to date with technological advancements and compliance requirements in the medical industry.

What skills and qualifications are needed to thrive as a medical device design engineer?

To thrive as a Medical Device Design Engineer, you need a solid background in biomedical engineering, mechanical engineering, or a related field, with expertise in product development and regulatory compliance. Familiarity with CAD software, prototyping tools, and standards such as ISO 13485 and FDA regulations is typically required. Strong problem-solving abilities, creativity, and effective communication skills set top performers apart in this role. These competencies are crucial for developing innovative, safe, and regulatory-compliant medical devices that improve patient outcomes.

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

Medical Device Design Engineers regularly work alongside professionals from regulatory, quality assurance, clinical, and manufacturing teams. They participate in design reviews, translate clinical needs into technical requirements, and ensure designs meet safety and compliance standards. Effective communication and teamwork are essential, as engineers must incorporate feedback, address concerns from various stakeholders, and document changes throughout the development lifecycle. This collaborative approach helps ensure the final product is both effective and compliant with industry regulations.

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

AspectMedical Device Design EngineerMechanical Engineer
Required CredentialsBachelor's in biomedical, mechanical engineering, or related; certifications like Certified Biomedical Equipment Technician (CBET) are commonBachelor's in mechanical engineering; optional certifications like Professional Engineer (PE)
Work EnvironmentMedical device companies, healthcare settings, R&D labsManufacturing, automotive, aerospace, R&D labs
Industry UsageDesigning and developing medical devices, ensuring regulatory complianceDesigning mechanical systems across various industries

Medical Device Design Engineers focus on creating and refining medical devices, ensuring they meet health regulations and user needs. Mechanical Engineers have a broader scope, working on mechanical systems in multiple industries. While both roles require engineering fundamentals, Medical Device Design Engineers specialize in healthcare applications and regulatory standards.

More about Medical Device Design Engineer jobs

What states have the most Medical Device Design Engineer jobs?

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

What are popular job titles related to Medical Device Design Engineer jobs?

For Medical Device Design Engineer jobs, the most frequently searched job titles are:

Medical Device Design Engineer jobs near you
Infographic showing various Medical Device Design Engineer job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 14% Part Time, and 6% Contract. Highlights an 87% Physical, 1% Hybrid, and 12% Remote job distribution, with an average salary of $103,662 per year, or $49.8 per hour.

Medical Device Engineer or Materials Scientist (Implantable Device Degradation)

Bethesda, MD • On-site

Tunnell Government Services
See more jobs at Tunnell Government Servicesexternal

Full-time

Re-posted 12 hours ago

Job description

Tunnell Government Services, Inc., is comprised of the industry's leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us.
Medical Device Engineer or Materials Scientist (Implantable Device Degradation) SME Position Description - 12 Month Term Position
The successful candidate will be either an Engineer (Biomedical, Chemical, Mechanical) or Materials Scientist and Medical Device subject matter expert, with extensive experience involving degradation (fretting, wear, and corrosion) of implantable medical devices.
They will provide scientific, technical, product development, product validation, and sustaining engineering advice as part of regulatory review of medical devices, with specific attention to premarket submissions that include mechanical functions. Such submissions include Premarket Notification (510(k)), Premarket Approval Application (PMA), etc.
The candidate should possess expertise and/or direct experience enabling the competent analysis of key components of the regulatory approach to assess device risk to a patient, a user of a device, or others in the environment of use. These include, but are not limited to analysis of aspects such as device design and modeling, analysis and simulation, material selection, prototyping and testing, manufacturing, documentation, and human factors/ergonomics.
The candidate should be familiar with applicable industry standards and regulatory requirements, such as, but not limited to, FDA Guidances (Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices), US regulatory standards (21 CFR Part 820 -- Quality System Regulation), and ANSI standards (ANSI/AAMI/ISO 14971: Medical devices - Applications of risk management to medical devices).
The candidate should also possess expertise, and/or direct experience enabling them to act as a subject matter expert on matters pertaining to medical device basic safety and essential performance. The candidate should also have experience involving the design and analysis of medical device systems, and performance of, and interpretation of results produced through standardized device testing approaches, in support of regulatory approval. The candidate should have appropriate training and experience necessary to provide effective consulting support in medical devices areas such as but not limited to shear stress evaluation, flow optimization, and standardized safety testing (i.e. ISO 10993-4). The candidate's experience should include knowledge of applicable standards, testing procedures, testing equipment, verification and validation of methods, preparation of test plans, reporting of results.
Qualifications
  • The candidate must possess an advanced degree (MS, PhD) in in the field of Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Science, or equivalent.
  • The candidate must possess specific, demonstrable expertise and experience involving degradation (fretting, wear, corrosion) of implantable medical devices, preferably orthopedic and cardiovascular implants. Prior work experience and/or publications in peer-reviewed sources is necessary to demonstrate qualifications.
  • The candidate must have experience with mechanical and chemical performance testing of orthopedic and cardiovascular medical device implants.
  • 10 years of experience is required (direct experience in medical device engineering and/or materials science)
  • General knowledge and experience with a variety of medical device development technical disciplines
  • Experience with directly supporting FDA 510(k) and related regulatory submissions
  • Exceptionally strong written and verbal communication skills
  • Ability to communicate well with others using excellent written and verbal communication skills.
  • Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel.
  • Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.)

Responsibilities
  • The primary focus of the role is to support analyses of medical device degradation relative to regulatory and technical aspects of mechanical/chemical engineering or materials science.
  • Provide consultation related to supporting medical device reviews (EUA, 510(k), PMA, IDE, Combination Devices, and De Novo marketing applications, Pre-submissions)
  • Participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders
  • Develop written reviews and correspondence
  • Write detailed documents and reports

Job Type: Full Time Employee
Schedule: Monday through Friday (No Holidays)
Location: This position is 100% telework.
Must be US Citizen or full Green Card holder.
Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.

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