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Medical Device Validation Engineer Jobs in Michigan

Medical Device Assembly

Wixom, MI ยท On-site

$16 - $17/hr

Assemble medical devices and components according to engineering drawings, work instructions, and ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

Medical Device Assembly

Wixom, MI ยท On-site

$16 - $17/hr

Assemble medical devices and components according to engineering drawings, work instructions, and ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

Medical Device Assembly

Wixom, MI ยท On-site

$16 - $17/hr

Assemble medical devices and components according to engineering drawings, work instructions, and ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

Be Seen First

Develop and execute verification and validation (V&V) test protocols; author associated technical ... and Class II medical device design controls. * Help stand up engineering processes and ...

New

Neogen is looking to hire a Mechanical Validation Engineer who would be responsible for overseeing ... Benefits starting on Day One - Medical, dental, and vision coverage begin on your first day of ...

As a Medical Device Driver, you will be responsible for the distribution and delivery of products ... Valid Driver's license with good driving record and no restrictions * Ability to lift, push, pull ...

Validation Engineer - Powertrain

Plymouth, MI ยท On-site

$85K - $107K/yr

... medical, dental, vision, short-term disability insurance, and long-term disability insurance to ... device, recruiting system usage/interaction, security and preference information. Rivian may use ...

Validation Engineer - Powertrain

Plymouth, MI ยท On-site

$85K - $107K/yr

... medical, dental, vision, short-term disability insurance, and long-term disability insurance to ... device, recruiting system usage/interaction, security and preference information. Rivian may use ...

We are seeking a Senior AI Validation Engineer to design and implement testing strategies ... medical, dental, vision, and prescription drug coverage -- ensuring you and your family stay ...

New

Validation Engineer - Powertrain

Plymouth, MI ยท On-site

$85K - $107K/yr

... medical, dental, vision, short-term disability insurance, and long-term disability insurance to ... device, recruiting system usage/interaction, security and preference information. Rivian may use ...

EXPLEO USA is looking for an Automotive Test & Validation Engineer to join a dynamic and expanding ... Comprehensive Benefits for you and your dependents - Extensive Medical Plans, Dental, Vision, HSA ...

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Showing results 1-20

Medical Device Validation Engineer information

What are some common challenges faced by medical device validation engineers during the validation process?

Medical Device Validation Engineers often encounter challenges such as ensuring compliance with evolving regulatory standards, managing tight project timelines, and coordinating cross-functional teams. Additionally, they must address unexpected technical issues that arise during testing and validation, and meticulously document results to meet quality and audit requirements. Effective communication and adaptability are crucial for successfully navigating these challenges and delivering safe, effective medical devices.

What does a medical device validation engineer do?

A Medical Device Validation Engineer is responsible for ensuring that medical devices meet regulatory and quality standards before they reach the market. They design and execute tests to validate that products perform as intended, documenting procedures and results to comply with industry regulations such as FDA and ISO guidelines. Their work involves collaborating with design, manufacturing, and quality assurance teams to identify risks and verify that devices are safe and effective for use. This role is crucial for patient safety and for a company's ability to market medical products globally.

Are medical device validation engineers in demand?

Medical device validation engineers are in high demand due to the increasing regulation and complexity of medical devices. They play a critical role in ensuring compliance with standards like ISO 13485 and FDA requirements, and their expertise in validation, testing, and quality assurance is sought after in the healthcare industry.

What is the difference between Medical Device Validation Engineer vs Quality Assurance Engineer?

AspectMedical Device Validation EngineerQuality Assurance Engineer
CredentialsEngineering degree, certifications like CQE or validation-specific trainingEngineering or related degree, CQE or QA certifications
Work EnvironmentDesign validation, process validation, testing labsAudits, process improvements, compliance documentation
Industry UsageProduct development, validation phases in medical device manufacturingEnsuring overall product quality, compliance, and process control

The Medical Device Validation Engineer focuses on validating medical devices through testing and process validation, ensuring products meet regulatory standards. In contrast, the Quality Assurance Engineer oversees overall quality systems, audits, and compliance processes. Both roles require similar certifications and work within the medical device industry, but their core responsibilities differ in scope and focus.

What are the key skills and qualifications needed to thrive as a medical device validation engineer?

To thrive as a Medical Device Validation Engineer, you need a strong background in biomedical engineering or a related field, with expertise in validation protocols, regulatory compliance, and risk analysis. Familiarity with technical standards such as ISO 13485, FDA 21 CFR Part 820, and tools like statistical analysis software and validation management systems is essential. Attention to detail, problem-solving abilities, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills are crucial to guarantee that medical devices meet regulatory requirements, function safely, and reach the market efficiently.
What are popular job titles related to Medical Device Validation Engineer jobs in Michigan? For Medical Device Validation Engineer jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Medical Device Validation Engineer jobs in Michigan look for? The top searched job categories for Medical Device Validation Engineer jobs in Michigan are:
What cities in Michigan are hiring for Medical Device Validation Engineer jobs? Cities in Michigan with the most Medical Device Validation Engineer job openings:
Infographic showing various Medical Device Validation Engineer job openings in Michigan as of August 2026, with employment types broken down into 61% Full Time, 6% Temporary, and 33% Contract. Highlights an 94% In-person, and 6% Remote job distribution.

Medical Device Assembly

Excel Medical Products

Wixom, MI โ€ข On-site

$16 - $17/hr

Full-time

Posted 19 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.