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Medical Device Development Jobs (NOW HIRING)

Pay Rate Low: 22 | Pay Rate High: 25 Medical Device Assembler Santa Rosa, CA | 4/10 Schedule | $22 ... Strong training program with significant investment in employee development * Access to employee ...

Minimum of four years experience in medical device development, manufacture and/or testing, with demonstrated knowledge of US, Canada and EU medical device regulatory requirements, experience with ...

Johnson & Johnson is rapidly expanding and is immediately hiring qualified Medical Device Assemblers to support production demand and new product development. Position Summary: As a Medical Device ...

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Medical Device Development information

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$29K

$53.4K

$81K

How much do medical device development jobs pay per year?

As of Jun 30, 2026, the average yearly pay for medical device development in the United States is $53,418.00, according to ZipRecruiter salary data. Most workers in this role earn between $42,500.00 and $60,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in Medical Device Development, and why are they important?

To thrive in Medical Device Development, you need expertise in engineering or life sciences, a solid understanding of regulatory requirements, and often an advanced degree such as a master's or Ph.D. in a relevant field. Familiarity with CAD software, prototyping tools, and knowledge of FDA or ISO regulatory standards is typically required. Strong problem-solving abilities, collaboration, and effective communication distinguish top professionals in this field. These skills ensure the development of safe, innovative, and compliant medical devices that meet both user needs and regulatory standards.

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

AspectMedical Device DevelopmentMedical Device Quality Assurance
CredentialsEngineering degrees, certifications like RAPS or regulatory trainingQuality certifications, ISO 13485, regulatory compliance training
Work EnvironmentDesign labs, R&D teams, product development settingsManufacturing sites, quality control labs, compliance departments
Industry UsageDesigning and creating new medical devicesEnsuring devices meet quality and regulatory standards

Medical Device Development focuses on designing and creating new medical devices, involving engineering and product innovation. Medical Device Quality Assurance ensures these devices meet safety, quality, and regulatory standards through testing and compliance processes. Both roles are essential in the medical device industry but serve different functions in the product lifecycle.

What are some common challenges faced by professionals in medical device development, and how can they be addressed?

Professionals in medical device development frequently encounter challenges such as navigating complex regulatory requirements, ensuring product safety and efficacy, and managing cross-functional collaboration between engineering, clinical, and regulatory teams. Addressing these challenges requires staying updated on evolving regulations, fostering open communication among diverse team members, and implementing robust quality control processes. Proactively engaging with regulatory bodies and regularly reviewing project milestones can help streamline development and reduce the risk of costly delays.

What is medical device development?

Medical device development is the process of designing, creating, testing, and bringing medical devices to market. This process involves multiple stages, including concept development, prototyping, preclinical and clinical testing, regulatory approval, and manufacturing. The goal is to ensure that new devices are safe, effective, and meet regulatory standards before they are used by healthcare professionals or patients. Teams in medical device development often include engineers, scientists, regulatory specialists, and quality assurance professionals.
More about Medical Device Development jobs
What cities are hiring for Medical Device Development jobs? Cities with the most Medical Device Development job openings:
What states have the most Medical Device Development jobs? States with the most job openings for Medical Device Development jobs include:
Engineer Senior, Drug Delivery Medical Device (JP9612)

Engineer Senior, Drug Delivery Medical Device (JP9612)

3 Key Consulting

Thousand Oaks, CA

$110K - $151K/yr

Other

Posted 18 days ago


Job description

Job Title: Engineer Senior, Drug Delivery Medical Device (JP9612)
Location: Thousand Oaks, CA.
Employment Type: Contract
Business Unit: FPT Development Product Engineering
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 1/3/2022
3 Key Consulting is hiring a Senior Engineerfor a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Senior Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Senior Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development. Responsibilities include:
  • Work cross-functionally with individuals and project teams in Marketing, Operations, and Development.
  • Create and assess product requirements to determine technical coverage and proper integration different subsystems.
  • Create and execute to project plans and schedules.
  • Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
  • Provide deep technical assistance for junior engineers.

Why is the Position Open?
Planned project.
Top Must Have Skills:
  • Design controls.
  • Mechanical testing.
  • Drug delivery experience.
  • Risk base process.
  • Presentation skills.

Day to Day Responsibilities:
  • Author device documentation to support development, planning, verification, validation, and transfer.
  • Author test protocols and execute mechanical testing of drug delivery devices.
  • Presentation and communication skills (within program teams).
  • Execute and deliver within regulated development processes.
  • Proactively maintains close communication with technical leads.

Basic Qualifications:
  • BS in Engineering and previous experience in a medical device industry.
  • 10 years' current experience with engineering processes and procedures.
  • Led projects from development through the 510k and PMA approval process.
  • Strong background in engineering and commercialization of electro-mechanical medical devices.
  • Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
  • Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
  • Experience in drug/device combination product design and development.
  • Familiar with the following standards:
    • Quality System Regulation.
    • 21CFR820.
    • Risk Management ISO 14971.
    • EU Medical Device requirements Council Directive 93/42/EEC.
    • Medical Electrical Equipment EN 60601.
  • Small scale device assembly experience.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
  • Strong problem solving, risk assessment, and risk management skills.
  • Must be capable of working on multiple projects in a deadline driven environment.
  • MERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!!

Red Flags:
  • Less than 5 years of experience.
  • Jumpy job history.
  • Lack of enthusiasm and not self-motivated.

Interview process:
Video Skype Panel Interview
We invite qualified candidates to sendyour resume toresumes@3keyconsulting.com. Ifyou decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our websitewww.3keyconsulting.com/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.