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Combination Product Medical Device Engineer information

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$53K

$144.1K

$205K

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

As of Aug 15, 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 is a combination product medical device engineer?

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.
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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 August 2026, with employment types broken down into 72% Full Time, 3% Temporary, and 25% Contract. Highlights an 84% In-person, 3% Hybrid, and 13% Remote job distribution, with an average salary of $144,072 per year, or $69.3 per hour.

Senior Device Engineer, Pharmaceutical R&D

Transpire BIO Inc.

Weston, FL • On-site

$99K - $136K/yr

Full-time

Re-posted 3 days ago

Job description

Position Summary
The Senior Device Engineer is responsible for device engineering activities in the context of pharmaceutical research and development (R&D). The device mechanical engineer will be responsible for early to late-stage device development activities and commercialization of drug-device combination products. The Device engineer will be responsible for design, prototyping, technical analysis, and testing of orally inhaled and nasal drug products (OINDPs). Provide device engineering leadership in the direction, initiation, planning, coordination, implementation, execution, control, and completion of specific device project(s) ensuring consistency with organizational strategy, commitments, and goals. The device engineer will need to ensure that the device designs meet user needs, regulatory and quality requirements, and consider manufacturability. This is a hands-on position which requires daily tactical responsibilities leading up to strategic decisions.
Essential Duties and Responsibilities
  • In support of the Product Development Teams, provide technical leadership in the device development area.
  • Execute design and development of orally inhaled and nasal drug products (OINDPs) following design controls.
  • Lead and execute analysis for device and product characterization, design feasibility, and design verification.
  • Lead and execute technical analyses including statistical analysis and tolerance analysis.
  • Lead root cause investigations.
  • Support scale-up and commercialization efforts.
  • Document studies and author documents per US FDA, EMA, MHRA and other global health authority requirements.
  • Interface and lead activities with third party contract research, development, and manufacturing organizations.
  • Contribute towards and maintain device design history files (DHF).
  • Document standard operating procedures (SOPs) for design controls in the context of pharmaceutical drug-device combination products.
  • Provide project updates/reporting through program governance.
  • Provide leadership and support for inter-site best practices (technology transfer, process validation, etc.) and phase appropriate guidelines and policies.
  • Execute project strategy, priorities, and milestones ensuring visibility and accountability.
  • Proactively lead with integrity and engage cross functional project teams and stakeholders.
  • Support organizational / departmental initiatives.
  • Prepare and conduct presentations to all levels of the organization which may include project technical and budgetary information.

Required Qualifications
  • A M.S, in Mechanical Engineering, Electrical Engineering, Material Sciences or related discipline with 7 to 10 years, B.S. with 10 to 14 years device development experience in pharmaceutical or related field.
  • Experience with device development in the context of pharmaceutical R&D and product development is a must to have.
  • Must possess expert knowledge of mechanical design with preference for SolidWorks.
  • Must possess expert knowledge of tools to conduct statistical and tolerance analysis.
  • Must possess knowledge of manufacturing processes including injection molding and metal machining processes.
  • Must possess knowledge of regulations and standards including US 21 CFR Part 820, ISO 13485, ISO 14971, ISO 10993, EU MDR etc.
  • Experience with device assembly processes including manual, semi-automated and/or commercial scale automated processes is a plus.
  • Experience in development of orally inhaled and nasal drug products (OINDPs) is a plus.
  • Experience in mold tool design, optimization and qualification is a plus to have.
  • Experience with Notified Bodies and CE marking is a plus.
  • Strong English language skills including writing ability and oral communication.
  • Demonstrates good judgment as well as cultural, social, and environmental awareness.

Preferred Qualifications
  • Experience in a regulated laboratory (pharma, biotech, medical device, mechanical, or environmental)
  • Knowledge of GMP, GLP, or ISO standards

Why Join Us?
We are a fast-growing pharmaceutical startup dedicated to innovation and improving patient outcomes. Join us to gain hands-on experience in a growing pharmaceutical business, get exposure to various functions with opportunities for career development and work in a collaborative and supportive work environment.

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