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Medical Device Validation Engineer Jobs in Michigan

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 ...

Senior Validation Engineer

Rochester, MI · On-site

$82K - $137K/yr

Use Your Power for Purpose The Rochester Senior Validation Engineer is responsible for planning ... Experience with sterile products and medical devices * Strong analytical and problem-solving skills

Senior Validation Engineer

Rochester, MI · On-site

$82K - $137K/yr

Maintain the Site Validation Master Plan, support regulatory audits, and represent engineering ... Experience with sterile products and medical devices * Strong analytical and problem-solving skills

Senior Validation Engineer

Rochester, MI · On-site

$82K - $137K/yr

Maintain the Site Validation Master Plan, support regulatory audits, and represent engineering ... Experience with sterile products and medical devices * Strong analytical and problem-solving skills

Bachelor's degree in Computer Science, Computer Engineering, Electrical Engineering, or a related ... medical, dental, vision, and prescription drug coverage -- ensuring you and your family stay ...

New

Showing results 21-40

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.

Automotive Test & Validation Engineer

Expleo

Troy, MI

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 19 days ago


Job description

Overview

EXPLEO USA is looking for an Automotive Test & Validation Engineer to join a dynamic and expanding team in Troy, Michigan.

Responsibilities:

  • Review and analyze test service requests and customer specifications in collaboration with the Product Project Team Member and Quality PTM, challenging requirements and defining the final validation plan.
  • Define requirements for specific tools, benches, and characterization/reliability testing, including associated budgets.
  • Develop detailed validation plans and test specifications to meet both customer requirements and internal quality targets.
  • Schedule and manage validation activities, coordinating laboratory resources such as technicians, tools, and test equipment.
  • Act as the primary point of contact between the customer and project team for environmental validation activities across multiple global locations.
  • Collaborate closely with project teams to support design improvements and ensure product performance targets are met.
  • Manage configuration and logistics of tested parts and lead validation FMEA generation.
  • Participate in design reviews (software, hardware, and product) and contribute to problem resolution and FMEA analysis.
  • Oversee laboratory planning, resource allocation, and validation cost management.
  • Support and govern test setup, execution, and verification using laboratory equipment such as thermal chambers and IP testing systems.
  • Collaborate with the Methods & Tools team to develop and optimize test environments and validation processes.
  • Oversee test script development using National Instruments LabVIEW and TestStand.
  • Ensure compliance with Quality Management Systems and industry standards (ASPICE, IATF/ISO standards).
  • Generate detailed test reports, conduct peer reviews, and communicate validation status regularly to stakeholders.
  • Lead problem management activities, including failure analysis, customer communication, and cross-functional reviews.
  • Drive test efficiency improvements by reducing cycle times, automating test benches, and enhancing laboratory tools and processes.
  • Support continuous improvement initiatives and participate in lessons learned across projects.

Requirements:

  • Bachelor of Science in Engineering (e.g., Computer Engineering, Electronic Engineering, Mechatronics, Mechanical Engineering, or related field).
  • Minimum of 5 years of experience in test and validation engineering within the automotive or similar industry.
  • Strong experience with National Instruments LabVIEW and/or TestStand (certification preferred).
  • Proficiency in programming languages such as Python, Java, C, or C++.
  • Experience with instrumentation and hardware interfacing (PXI, PCI, USB, RS232, GPIB).
  • Solid understanding of automotive electronic systems and validation methodologies.
  • Experience with accelerated life testing and environmental validation.
  • Ability to read, analyze, and interpret complex technical documents and schematics.
  • Strong knowledge of MS Office tools.
  • Excellent communication skills with the ability to work in a global, cross-functional team environment.
  • Demonstrated problem-solving ability, adaptability, and strong attention to detail.

What We Offer:

At Expleo USA, we value expertise, innovation, and collaboration. By joining our client's team, you'll work on high-impact automotive programs while enjoying a supportive and collaborative work environment.

  • Competitive Compensation - Up to 95K annually. Final compensation is determined based on skill alignment, years of experience, and fair, marketbased rates by geography.
  • Comprehensive Benefits for you and your dependents - Extensive Medical Plans, Dental, Vision, HSA with company contribution, company sponsored Life Insurance and Short / Long term disability insurance, a host of voluntary plans including legal, hospital, accident, pet wellness, and 401k with matching
  • Paid Holidays and Paid Time Off
  • Career Development and Advancement - Expleo is a global company in 29 Countries worldwide with a high focus on development
  • Strong Team Culture - Collaborate with experienced professionals who value precision, performance, and teamwork 

Expleo is a trusted partner for end-to-end, integrated engineering, production support, MRO, and quality services, with a presence in over 30 countries. To find out more, visit www.expleogroup.com

Expleo is an equal opportunity employer. We commit to non-discrimination in all stages of the recruitment process, ensuring fair and unbiased hiring practices.

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Employment Type: FULL_TIME