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Combination Product Medical Device Engineer Jobs

Gilead Sciences, Inc.

Device Engineer III

Foster City, CA · On-site

$117K - $152K/yr

We are seeking a highly skilled and proactive Device Engineer III to support testing, method ... Experience in combination product development , medical device testing, or pharmaceutical/biotech ...

Kymanox

(Contract) Engineer, PD&C

Boston, MA · On-site

... Product Engineer or Scientist with a strong technical and/or operations background in the ... Conducting testing activities, including combination product and medical device design verification ...

Kymanox

(Contract) Engineer, PD&C

Boston, MA · Hybrid

... Product Engineer or Scientist with a strong technical and/or operations background in the ... Conducting testing activities, including combination product and medical device design verification ...

kindeva

Senior Device Engineer

Maryland Heights, MO · On-site

$101K - $138K/yr

Experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering role or related field * B.S. Degree in Engineering discipline with 7 - 9 years experience * M.

kindeva

Senior Device Engineer

Maryland Heights, MO

$101K - $138K/yr

Experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering role or related field * B.S. Degree in Engineering discipline with 7 - 9 years experience * M.

kindeva

Senior Device Engineer

Maryland Heights, MO

$101K - $138K/yr

Experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering role or related field * B.S. Degree in Engineering discipline with 7 - 9 years experience * M.

kindeva

Senior Device Engineer

Maryland Heights, MO

$101K - $138K/yr

Experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering role or related field * B.S. Degree in Engineering discipline with 7 - 9 years experience * M.

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All JobsCombination Product Medical Device Engineer Jobs

Combination Product Medical Device Engineer information

See salary details

$53K

$144.1K

$205K

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

As of Jul 5, 2026, the average yearly pay for combination product medical device 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 some typical challenges faced by a Combination Product Medical Device Engineer when working on cross-functional teams?

Combination Product Medical Device Engineers often collaborate with professionals from pharmaceutical, biotechnology, and device engineering backgrounds. One common challenge is ensuring clear communication across disciplines, as each team may have different regulatory requirements and technical needs. Balancing the integration of drug and device components while meeting strict FDA and ISO standards can also be complex. Proactively addressing these challenges through regular cross-functional meetings and thorough documentation helps ensure project success and compliance.

What are Combination Product Medical Device Engineers?

Combination Product Medical Device Engineers are professionals who design, develop, and oversee the manufacturing of medical products that integrate drugs, devices, and/or biological components. They ensure these products meet regulatory standards and function safely and effectively for patients. Their work often involves cross-disciplinary collaboration, detailed documentation, and rigorous testing to comply with FDA or other international requirements. These engineers play a crucial role in bringing innovative combination therapies and delivery systems to market.

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

AspectCombination Product Medical Device EngineerMedical Device Quality Engineer
CredentialsBachelor's or higher in engineering, regulatory knowledgeBachelor's or higher, quality standards expertise
Work EnvironmentDesign, development, and testing of combination productsQuality assurance, compliance, and validation processes
Industry UsagePharmaceutical and medical device sectors involving combination productsMedical device manufacturing and regulatory compliance

The Combination Product Medical Device Engineer focuses on designing and developing products that integrate drugs, devices, or biologics, requiring cross-disciplinary skills. In contrast, the Medical Device Quality Engineer emphasizes ensuring product quality, compliance, and validation throughout manufacturing. Both roles are essential in the medical device industry but serve different stages of product lifecycle and expertise areas.

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

To thrive as a Combination Product Medical Device Engineer, you need a strong background in biomedical or mechanical engineering, familiarity with drug delivery systems, and experience in regulatory standards like FDA 21 CFR and ISO 13485. Proficiency with CAD software, risk management tools, and knowledge of quality management systems (QMS) are typically required, along with certifications such as Six Sigma or PMP being advantageous. Strong problem-solving abilities, attention to detail, and effective cross-functional communication are critical soft skills for excelling in this role. These competencies ensure the development of safe, compliant, and innovative combination products that meet both technical and regulatory requirements.
More about Combination Product Medical Device Engineer jobs
What cities are hiring for Combination Product Medical Device Engineer jobs? Cities with the most Combination Product Medical Device Engineer job openings:
What states have the most Combination Product Medical Device Engineer jobs? States with the most job openings for Combination Product Medical Device Engineer jobs include:
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Combination Product Medical Device Engineer jobs near you
Infographic showing various Combination Product Medical Device Engineer job openings in the United States as of June 2026, with employment types broken down into 75% Full Time, 3% Part Time, 1% Temporary, and 21% Contract. Highlights an 95% Physical, 2% Hybrid, and 3% Remote job distribution, with an average salary of $144,072 per year, or $69.3 per hour.
Engineer Senior, Biotech Combination Products - Hybrid (JP13709)

Engineer Senior, Biotech Combination Products - Hybrid (JP13709)

3 Key Consulting

Thousand Oaks, CA • Hybrid

$44 - $48/hr

Other

Posted 29 days ago

Job description

Job Title:Engineer Senior, Biotech Combination Products - Hybrid (JP13709)
Location:Thousand Oaks, CA. 91320 (Hybrid)
Business Unit:Prefilled Syringes - New Product Development
Employment Type:Contract
Duration:1+ year with likely extensions and/or conversion to a permanent position.
Rate: $44 - $48/hour W2 with benefits
Posting Date:2/11/2025.
Notes: Onsite Thousand Oaks, CA - 2-3 days per week onsite
3 Key Consulting is hiring! We are recruiting anEngineer Senior, Biotech Combination Productsfor a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
B.S. and a minimum of 3+ strong years of experience. 5 YOE is ideal.
Experience working on prefilled syringes or vials. Combination product experience. Regulatory experience.
The Device Engineer will participate in the medical device/combination product design, development, and commercialization activities for drug delivery devices, focusing on prefilled syringes.
Key responsibilities include:
  • Leading test procedure development and functional test execution
  • Leading material inventory management for prefilled syringe programs, including material forecasting and material custody across multiple sites and functional groups.
  • Authoring technical plans and reports
  • Performing advanced statistical data analysis
  • Supporting Leading technical assessments and root cause investigations as well as planning and delegation of sub-tasks to other team members.
  • Transfer of information to manufacturing sites, engagement with suppliers
  • Maintenance of Design History File content consistent with Good Documentation Practices
  • Training junior staff on physical test methods, sample preparation protocols and procedures, and effective report writing.
  • Reviewing primary data collected from peers in support for various design controls activities, including characterization and design verification.
  • Supporting design transfer activities by leading cross-functional coordination of sample procurement and testing.
  • Supporting the setting of specification limits for platform devices through human factors studies benchtop testing.
Essential Skills:
  • Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
  • Plans and conducts work requiring judgment in the independent evaluation, selection, and adaptation and modification of standard techniques/procedures/criteria, and devises new approaches to encountered challenges.
  • Generates and maintains design specifications, protocol and report writing, prototyping, design of experiments/statistical process control product optimization, design verification & validation, FMEA, etc.
  • System level root cause investigation; CAD/SolidWorks proficiency; tolerance analysis; capability analysis.
  • Coordinate and implement design improvements with development partners.
  • Collaborate with scientists and engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
  • Accountability of maintaining technical records within product design history files.
  • Individual contributor with leadership attributes to effectively represent device engineering within a large network/matrix organization.
  • Working proficiency and familiarity with governing standards and regulations, including Quality System Regulation (21CFR820) and Risk Management (ISO 14971).
Preferred Qualifications:
  • Degree in the field of Mechanical or Biomedical Engineering, or related field
  • Medical device industry and/or regulated work environment experience
  • Excellent written and verbal communication skill
  • Understanding and experience in:
  • Development/commercialization of medical devices and knowledge of manufacturing processes
  • Initiating and bringing complex projects to conclusion
  • Ability to work independently and dynamic cross functional teams
  • Design controls
  • Failure investigation
  • Applied statistics
Top Must Have Skill Sets:
  • Pharma background.
  • Physical testing experience
  • Design controls experience

Red Flags:
Poor communication skills
Lack of hands on testing experience
Why is the Position Open?
Supplement to current team
Interview Process:
One rounds of interviews
We invite qualified candidates to sendyour resume torecruiting@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.

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