ZipRecruiter

Log In

1

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 ...

Celldex Therapeutics

Senior Device Engineer

Hampton, NJ · On-site

$133K - $173K/yr

The Senior Device Engineer will drive the end-to-end development of a device combination product ... combination products or medical devices. * Possess strong project management and interpersonal ...

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

$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 · 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 · 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.

next page

Showing results 1-20

People also search for

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 Jun 11, 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:
What job categories do people searching Combination Product Medical Device Engineer jobs look for? The top searched job categories for Combination Product Medical Device Engineer jobs are:
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 3% Locum Tenens, 88% Full Time, 6% Part Time, and 3% Nights. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $144,072 per year, or $69.3 per hour.
Device Development & Testing Engineer - Drug Delivery / Combination Products (Lab, Failure An...

Device Development & Testing Engineer - Drug Delivery / Combination Products (Lab, Failure An...

3 Key Consulting

Thousand Oaks, CA • Hybrid

$36 - $41/hr

Other

Posted 3 days ago

Job description

Job Title: Device Development & Testing Engineer - Drug Delivery / Combination Products (Lab, Failure Analysis, Design Controls)- (JP15205)
Location: Thousand Oaks, CA. 91320 - Hybrid
Employment Type: Contract
Business Unit: Commercial Drug Product
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 04/08/2026
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply. The candidate will need to have availability to go onsite any day of the week, M-F. Hybrid schedule will be 3-4 days per week for the first 2 quarters and then determined depending on business needs.
3 Key Consulting is hiring a Device Development & Testing Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
Our ideal candidate willl:
  • Have strong laboratory testing experience, particularly with combination products and medical devices.
  • Possess a solid foundation in experimental methods and data analysis.
  • Be proficient in statistical tools and methodologies.
  • Demonstrate experience in failure analysis and implementing design solutions.
  • Have a proven ability to collaborate effectively within cross-functional teams.
  • Exhibit strong organizational skills and attention to detail, especially in maintaining design history files.
  • Show familiarity with regulatory and quality requirements for combination products and medical devices.
  • This role offers the opportunity to make a meaningful impact by leveraging technical expertise in a dynamic and innovative environment focused on advancing our client's portfolio of drug delivery devices.

The Device Engineer will play a critical role in the design, development, and lifecycle management of drug delivery devices, including prefilled syringes, with a focus on testing and analysis within a laboratory environment. This position requires strong experimental, analytical, and statistical skills to support technical operations and ensure the success of our client's combination product portfolio.
Key responsibilities include:
  • Conducting hands-on experimental testing to support failure investigations and root cause analysis.
  • Developing, executing, and refining test procedures to evaluate device performance and functionality.
  • Analyzing test data and applying statistical methods to derive actionable insights and recommendations.
  • Supporting design changes by leading testing efforts to assess and validate proposed modifications.
  • Participating in the scale-up, global launch, and continuous improvement of drug delivery devices.
  • Collaborating with contract manufacturers and suppliers to ensure device quality and performance standards are met.
  • Maintaining robust design history files for mechanical and electro-mechanical delivery devices.
  • Enhancing and expanding Amgen's delivery device platform as needed to meet evolving product and regulatory requirements.

Why is the Position Open?
Planned Project
Top Must Have Skills:
  • Problem solving (engineering skillset)
  • Organization (self-starter and project level management)
  • Communication (experience communicating at different levels and to different groups)
  • Nice to have: 1-2 years of experience

Day to Day Responsibilities:
  • 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
  • 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).

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Red Flags:
Missing two or more of the following four items:
  • Degree in the field of Mechanical or Biomedical.
  • 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
  • Inability to be present on site/support ATO-site based activities. This is a hybrid role, NOT fully remote.

Interview process:
Screening interview with myself, followed by a panel interview. Following the panel interviews, if a tie-breaker is needed, there may be a 3rd final round to go in depth on specifics the team felt needed further discussion.
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.

Apply