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Medical Device Validation Engineer Jobs in Michigan

Tekhawks LLC

Be Seen First

Electrical Design Engineer - Medical Device Industry

Kalamazoo, MI · On-site

Support verification and validation testing, including root cause analysis and redesign ... Maintain compliance with FDA and EU medical device regulations * Ability to be on customer site for ...

Tekhawks LLC

Be Seen First

Electrical Design Engineer - Medical Device Industry

Kalamazoo, MI · On-site

Support verification and validation testing, including root cause analysis and redesign ... Maintain compliance with FDA and EU medical device regulations * Ability to be on customer site for ...

Neogen

Mechanical Validation Engineer

Lansing, MI

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 ...

SiTime Corporation

Product Validation Engineer

Dexter, MI · On-site

$78K - $108K/yr

Job Summary The Product Validation Engineer will be responsible for productization of SiTime ... Benefits offered: 401k, health and wellness that includes medical, dental, vision, life, parental ...

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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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.

What engineers make $500,000?

Senior engineers in specialized fields such as petroleum, aerospace, or software engineering can reach or exceed a $500,000 annual salary, especially with experience, advanced skills, and leadership roles. Medical Device Validation Engineers typically earn less, but senior-level professionals with extensive expertise and certifications may approach high six-figure incomes in certain industries or companies.

How much does a validation engineer make at Pfizer?

A validation engineer at Pfizer typically earns between $70,000 and $100,000 annually, depending on experience, location, and certifications. Salaries may also include benefits such as health insurance and bonuses, with some roles requiring knowledge of validation protocols and regulatory standards.

Are validation engineers in demand?

Validation engineers, including those in the medical device industry, are in high demand due to strict regulatory requirements and the need for quality assurance. Their skills in validation protocols, risk management, and compliance with standards like ISO 13485 and FDA regulations make them valuable in manufacturing and quality assurance roles across healthcare and biotech sectors.

Do validation engineers make good money?

Validation engineers, including those in the medical device industry, typically earn competitive salaries that vary based on experience, location, and certifications. They often require knowledge of regulatory standards and validation tools, which can influence compensation levels. Overall, validation engineering is considered a well-paying profession within engineering fields.

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, and why are they important?

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 76% Full Time, 17% Part Time, and 7% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.
Validation Engineer - Manistee Area

Validation Engineer - Manistee Area

The Pivot Group

Manistee, MI

$76K - $116K/yr

Full-time

Posted 21 days ago

Job description

Validation Engineer - Manistee Area

Validation Engineer | Manistee, MI

Salary Range: $76,000 - $116,000 depending on experience

Are you a meticulous professional with a passion for excelling in validation engineer? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is dedicated to fostering meaningful relationships and supporting career growth. We are collaborating with companies in Manistee seeking experienced Validation Engineers.

We are building our network of talent in this field across West Michigan and the broader manufacturing region Pivot Group Network serves. Our partner companies may or may not have an immediate opening for this exact role today, but we actively look for skilled professionals in the regions where they operate. If there is alignment now or in the near future, we reach out.

The Opportunity

We are working with companies in Manistee that are adding Validation Engineers to their teams. These organizations value quality over speed in hiring. By connecting with us, you position yourself for opportunities that align with what you're looking for.

Key Responsibilities

  • Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes.
  • Perform risk assessments and generate validation plans for new and modified systems.
  • Analyze data and author validation reports summarizing testing results and conclusions.
  • Ensure compliance with regulatory requirements (e.g., FDA, ISO) and internal quality standards.
  • Investigate deviations and out-of-specification results during validation activities.
  • Support change control activities by assessing validation impact for proposed changes.
  • Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) on validation efforts.

Recommended Qualifications

  • Bachelor's degree in engineering or a related scientific discipline.
  • 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical device, pharmaceutical).
  • Demonstrated knowledge of GxP regulations and industry standards (e.g., FDA 21 CFR Part 820, ISO 13485).
  • Experience with various validation activities, including IQ, OQ, PQ for equipment, processes, and software.
  • Strong technical writing skills for authoring and reviewing validation protocols and reports.

Bonus Qualifications

  • Experience with Lean Manufacturing or Six Sigma methodologies.
  • Familiarity with data analysis tools (e.g., JMP, Minitab, Python, R).
  • Project management certification (e.g., PMP, CAPM).
  • Advanced degree in a relevant engineering or scientific field.
  • Experience with automation systems (e.g., PLC, SCADA, DCS).

Job Titles That Should Apply

Validation Engineer, Senior Validation Engineer, Principal Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Test Engineer (Validation), QA Validation Engineer, Validation Specialist, Validation Lead, Validation Consultant, Validation Analyst, Quality Engineer (Validation), Biomedical Engineer (Validation), Pharmaceutical Validation Engineer, Biotech Validation Engineer, Medical Device Validation Engineer

Why The Pivot Group Network

The Pivot Group Network was founded by manufacturing professionals who've been on both sides of the hiring process. Our clients are strategic—they partner with us because they want real insight into their roles and the people filling them, not a stack of resumes. We focus on match-driven placements built around what actually matters: Commute, Compensation, Culture, and Career trajectory. Learn more at https://www.thepivotgroup.org.

If you're ready to take the next step in your career and connect with a firm that values fit over speed, we invite you to reach out at https://www.thepivotgroup.org. The Pivot Group Network offers resources to support your search—market insights, resume feedback, and interview preparation. As our partnerships grow, we'll reach out with opportunities aligned with your goals. Thank you for considering this approach to career advancement.

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