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Medical Device Validation Engineer Jobs in Michigan

Stryker

Medical Device Driver

Novi, MI · On-site

$21.40/hr

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 ...

Tekhawks LLC

Product Safety Engineer

Kalamazoo, MI · On-site

... validation, commercialization, and sustaining engineering. The ideal candidate has strong experience with electrical safety, risk management, compliance testing, and medical device regulations while ...

Tekhawks LLC

Product Safety Engineer

Kalamazoo, MI · On-site

... validation, commercialization, and sustaining engineering. The ideal candidate has strong experience with electrical safety, risk management, compliance testing, and medical device regulations while ...

Rivian

Sr. Durability Validation Engineer

Plymouth, MI

$111K - $138K/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

Sr. Durability Validation Engineer

Plymouth, MI · On-site

$111K - $138K/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

Sr. Durability Validation Engineer

Plymouth, MI · On-site

$111K - $138K/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 ...

Biovire

Process Development Manager

Brighton, MI · On-site

... Validation, Engineering, and other cross-functional teams. The Role Reporting to the Director ... medical device manufacturing. This role leads a team of Process Engineers and ensures that ...

Biovire

Manager, Process Development

Brighton, MI · On-site

... Validation, Engineering, and other cross-functional teams. The Role Reporting to the Director ... medical device manufacturing. This role leads a team of Process Engineers and ensures that ...

Biovire

Manager, Process Development

Brighton, MI · On-site

$100K - $120K/yr

... Validation, Engineering, and other cross-functional teams. The RoleReporting to the Director ... medical device manufacturing.This role leads a team of Process Engineers and ensures that ...

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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 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.

Product Validation Engineer - Automotive Electrical Systems (High-Voltage Wiring Harness)

HTC Global Services

Allen Park, MI • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 25 days ago

Job description

Job Title
Product Validation Engineer - Automotive Electrical Systems (High-Voltage Wiring Harness)
Overview
We are seeking an experienced Product Validation Engineer to lead Design Verification Planning (DVP) and Product Validation (PV) activities for automotive electrical systems, with a primary focus on high-voltage wiring harnesses. This position is responsible for validation planning, cross-functional coordination, supplier collaboration, testing support, quality activities, and execution through vehicle launch. This is a validation leadership role and not a traditional Design & Release engineering position.
Work Arrangement: Hybrid (4 days per week onsite)
Key Responsibilities
  • Lead Design Verification Planning (DVP) and Product Validation (PV) activities.
  • Develop validation strategies, test plans, and prototype requirements.
  • Coordinate validation efforts with engineering, suppliers, manufacturing, and testing teams.
  • Track validation progress, engineering changes, and program milestones.
  • Support vehicle launches, quality improvements, and warranty investigations.
  • Lead Technical Design Reviews (TDRs).
  • Maintain validation documentation.
  • Support DFMEA, PPAP, APQP, root cause analysis, and continuous improvement activities.
  • Lead cross-functional validation efforts involving engineering, suppliers, quality, and manufacturing teams.

Required Qualifications
  • Bachelor's degree in Engineering (Electrical Engineering preferred; Mechanical or Mechatronics Engineering accepted).
  • 5-10 years of automotive engineering experience.
  • 5-10 years of experience with automotive electrical systems or wiring harnesses.
  • Experience leading Design Verification (DV) and Product Validation (PV).
  • Experience creating and managing Design Verification Plans (DVPs).
  • Experience with automotive product development processes.
  • Vehicle launch experience.
  • Knowledge of GPDS.
  • Experience using TeamCenter and/or CATIA.
  • Knowledge of PPAP, DFMEA, and APQP.
  • Experience with root cause analysis, 8D, and Six Sigma methodologies.
  • Strong cross-functional leadership and supplier coordination skills.
  • Strong written and verbal communication skills.

Preferred Qualifications
  • Master's degree in Engineering or a related field.
  • Experience with high-voltage wiring harnesses.
  • Experience with Electrical Distribution Systems (EDS).
  • Manufacturing or validation engineering experience.
  • Experience with bench, dyno, or vehicle testing.
  • Cost estimation experience.
  • Proficiency with Microsoft Office.
  • Experience with 3DX, WERS, Falcon, RPS, eCAR, or DCCS/ACCS.
  • Familiarity with AI productivity tools.

What Makes HTC A Great Place To Build Your Future
HTC Global Services wants you to join our team. Come build new things with us and advance your career. At HTC Global, you'll collaborate with experts, work alongside clients, and be part of high-performing teams driving success together. You'll have long-term opportunities to grow your career and develop skills in the latest emerging technologies.
At HTC Global Services, our employees have access to a comprehensive benefits package. Benefits can include Group Health (Medical, Dental, and Vision), Paid Time Off, Paid Holidays, 401(k) matching, Group Life and Disability insurance, Professional Development opportunities, Wellness programs, and a variety of other perks.
Our success as a company is built on inclusion and diversity. HTC Global Services is committed to providing a workplace free from discrimination and harassment, where every employee is treated with dignity and respect. We celebrate differences and believe that diverse cultures, perspectives, and skills drive innovation and success. HTC is an Equal Opportunity Employer and a proud National Minority Supplier. We seek to empower each individual, fostering an environment where everyone feels valued, included, and respected.
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