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Combination Product Medical Device Engineer Jobs in Michigan

Medical Device Assembly

Wixom, MI ยท On-site

$16 - $17/hr

Excel Medical Products in Wixom, MI is looking for a detail-oriented Medical Device Assembler to ... Assemble medical devices and components according to engineering drawings, work instructions, and ...

Medical Device Assembly

Wixom, MI ยท On-site

$16 - $17/hr

Excel Medical Products in Wixom, MI is looking for a detail-oriented Medical Device Assembler to ... Assemble medical devices and components according to engineering drawings, work instructions, and ...

Medical Device Assembly

Wixom, MI ยท On-site

$16 - $17/hr

Excel Medical Products in Wixom, MI is looking for a detail-oriented Medical Device Assembler to ... Assemble medical devices and components according to engineering drawings, work instructions, and ...

Staff Product Safety Engineer

Portage, MI ยท On-site

$100 - $125/hr

At Stryker, we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be ...

Conduct the development and evaluation of medical device designs which meet defined product ... Conduct thorough engineering and data analysis. Project Management * Responsible for project ...

Medical Device Product Development * Lead projects and evaluate design changes related to existing ... Conduct thorough engineering and data analysis. Project Management * Manage project schedules ...

Staff Product Safety Engineer

Portage, MI ยท On-site

$89K - $148K/yr

At Stryker, we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be ...

Staff Product Safety Engineer

Portage, MI ยท Hybrid

$89K - $148K/yr

At Stryker, we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be ...

Medical Device Product Development * Lead projects and evaluate design changes related to existing ... Conduct thorough engineering and data analysis. Project Management * Manage project schedules ...

Conduct the development and evaluation of medical device designs which meet defined product ... Conduct thorough engineering and data analysis. Project Management * Responsible for project ...

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Combination Product Medical Device Engineer information

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 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 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.

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 popular job titles related to Combination Product Medical Device Engineer jobs in Michigan?

For Combination Product Medical Device Engineer jobs in Michigan, the most frequently searched job titles are:

What job categories do people searching Combination Product Medical Device Engineer jobs in Michigan look for?

The top searched job categories for Combination Product Medical Device Engineer jobs in Michigan are:

What cities in Michigan are hiring for Combination Product Medical Device Engineer jobs?

Cities in Michigan with the most Combination Product Medical Device Engineer job openings:

Infographic showing various Combination Product Medical Device Engineer job openings in Michigan as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution.

Medical Device Assembly

Excel Medical Products

Wixom, MI โ€ข On-site

$16 - $17/hr

Full-time

Re-posted 18 days ago


Job description

About the Role:
Excel Medical Products in Wixom, MI is looking for a detail-oriented Medical Device Assembler to join their growing team. This is a great opportunity to be part of a precision-driven environment where your work directly impacts patient care and product quality. If you take pride in accuracy and craftsmanship, we want to hear from you!

Responsibilities:
  • Assemble medical devices and components according to engineering drawings, work instructions, and quality standards
  • Inspect finished assemblies for defects, dimensional accuracy, and compliance with specifications
  • Operate hand tools, fixtures, and assembly equipment in a cleanroom or controlled manufacturing environment
  • Document production activities, lot traceability, and quality records per FDA and ISO regulations
  • Identify and report non-conforming materials or process deviations to supervisors
  • Maintain a clean, organized, and safe workstation in accordance with GMP guidelines
  • Collaborate with quality and production teams to meet daily output and delivery goals
Requirements:
  • High school diploma or GED required
  • Prior experience in medical device assembly, electronics assembly, or precision manufacturing preferred
  • Ability to read and follow work instructions, BOMs, and technical drawings
  • Strong attention to detail and manual dexterity for fine assembly work
  • Familiarity with GMP, ISO 13485, or FDA quality system regulations is a plus
  • Ability to stand, sit, and perform repetitive tasks throughout an 8-hour shift
  • Reliable, punctual, and able to work effectively in a team-oriented environment
About Us:
Excel Medical Products is a trusted name in the medical device manufacturing industry, proudly serving healthcare professionals and patients from our facility in Wixom, MI. Our commitment to precision, quality, and innovation has earned us a reputation for excellence among our customers and partners. We foster a supportive workplace culture where employees are valued, trained, and empowered to grow their careers in the medical manufacturing field.