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Medical Device Validation Engineer Jobs in Minnesota

Cretex Medical Component and Device Technologies

$100 - $125/hr

Product Development, Validation & Technical Execution * Execute and support comprehensive test ... Strong knowledge of medical device regulations, quality systems, and risk management processes.

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Medical Device Validation Engineer information

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 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 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 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 popular job titles related to Medical Device Validation Engineer jobs in Minnesota?

For Medical Device Validation Engineer jobs in Minnesota, the most frequently searched job titles are:

What job categories do people searching Medical Device Validation Engineer jobs in Minnesota look for?

The top searched job categories for Medical Device Validation Engineer jobs in Minnesota are:

What cities in Minnesota are hiring for Medical Device Validation Engineer jobs?

Cities in Minnesota 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 Minnesota as of September 2026, with employment types broken down into 82% Full Time, and 18% Contract. Highlights an 94% In-person, and 6% Hybrid job distribution.

Medical Device Complaint Specialist

Moundsview, MN • On-site

Three Point Solutions
Recruiting and Staffing Services • 11 - 50 employees
Learn more about Three Point Solutionsexternal

$28 - $31/hr

Contractor

Re-posted 21 days ago

Job description

Job title :         Medical Device Complaint Specialist

Client :             Medical Device Manufacturing Company

Duration :        24 Months

Location :        Mounds View, MN 55112

Shift :               1st Shift (Hybrid – 4 Days Onsite, 1 Day Remote)

Description:

  • Support Medical Device Report (MDR) activities.
  • Review and process complaint records.
  • Manage adverse event reporting.
  • Monitor medical device surveillance.
  • Maintain MDR and ADE records.
  • Review clinical safety data.
  • Prepare safety summaries and reports.
  • Ensure regulatory compliance.
  • Support complaint investigations.
  • Collaborate with cross-functional teams.
  • Maintain quality documentation.
  • Support regulatory reporting projects.

Required Qualifications:

  • Bachelor's degree required.
  • 1–3 years of relevant experience.
  • Medical Device Reporting (MDR) experience.
  • Complaint handling experience.
  • Knowledge of regulatory compliance.
  • Strong analytical and critical thinking skills.
  • Excellent organizational and time management skills.
  • Strong written communication.
  • Attention to detail.
  • Ability to manage multiple priorities.

Preferred Qualifications:

  • Clinical background (RN or Healthcare Professional).
  • Biomedical Engineering background.
  • Experience in a regulated environment.
  • Knowledge of quality systems.
  • Medical device industry experience.
  • Experience with adverse event reporting.
  • Cross-functional collaboration experience.

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