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Medical Device Validation Engineer Jobs in Michigan

Excel Medical Products

Medical Device Assembly

Wixom, MI · 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 ...

Excel Medical Products

Medical Device Assembly

Wixom, MI · 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 ...

Excel Medical Products

Medical Device Assembly

Wixom, MI · 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 ...

Neogen

Mechanical Validation Engineer

Lansing, MI · On-site

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 ...

Rivian

Validation Engineer - Powertrain

Plymouth, MI · 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 ...

Rivian

Validation Engineer - Powertrain

Plymouth, MI · 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 ...

Rivian

Validation Engineer - Powertrain

Plymouth, MI · 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

Automotive Test & Validation Engineer

Troy, MI · On-site

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

Expleo

Automotive Test & Validation Engineer

Troy, MI

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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All JobsMedical Device Validation Engineer JobsMedical Device Validation Engineer Jobs in Michigan

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:
Medical Device Validation Engineer jobs near you
Infographic showing various Medical Device Validation Engineer job openings in Michigan as of July 2026, with employment types broken down into 77% Full Time, 15% Part Time, and 8% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution.

Mold Validation Engineer

Intellectt INC

Grand Rapids, MI • On-site

Contractor

Re-posted 2 days ago

Job description

Hello,

I hope you’re doing well.

My name is Vyshu, and I’m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Mold Validation Engineer based in Grand Rapids, MI / Dexter, MI / Minneapolis, MN with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at vyshnavi.t@intellectt.com

Job Title: Mold Validation Engineer
Locations: Grand Rapids, MI / Dexter, MI / Minneapolis, MN

Role Summary:
Responsible for executing injection mold validations (IQ/OQ/PQ) to ensure compliant, production-ready processes in a regulated (medical device) environment.

Key Responsibilities:

  • Lead mold validation activities: POD, IQ, OQ, PQ
  • Execute mold qualification phases (T0–PQ) and sampling runs
  • Develop validation protocols, reports, and documentation
  • Perform DOE, gate freeze studies, and process characterization
  • Apply RJG scientific molding and establish process windows
  • Troubleshoot molding, tooling, and material issues
  • Conduct FAI and ensure CTQ compliance
  • Support PFMEA, Control Plans, and production documentation
  • Collaborate with cross-functional teams and suppliers

Qualifications:

  • Bachelor’s in Engineering (Mechanical/Manufacturing/Plastics or related)
  • 6–8 years of injection molding validation experience
  • Experience in regulated industry (Medical Device/Pharma)
  • Strong expertise in IQ/OQ/PQ, DOE, and RJG scientific molding
  • Knowledge of cavity pressure analysis, Cpk/Ppk, and tolerances

Thanks & Regards,
Vyshnavi
Recruiter
Intellectt Inc 
vyshnavi.t@intellectt.com
Direct: 732 204 6550
Desk number: 732 412 6999 - Ext: 225