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Medical Device Validation Engineer Jobs in Minnesota

Gallin Associates

Sr. Engineer, Medical Device R&D

Edina, MN · On-site

$108K - $148K/yr

CLIENT CANNOT SPONSOR/TRANSFER WORK AUTHORIZATION RELOCATION ASSISTANCE Our client is a leading medical device developer focused on biologics and regenerative medicine applications and in growth-mode!

Gn

Hearing Care Professional/Medical Device Sales

Albert Lea, MN · On-site

$45K - $60K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Hearing Care Professional/Medical Device Sales - Albert Lea, MN Salary Potential Ranges from $45 ... Valid driver's license and reliable transportation. * Passion for helping people and making a ...

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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 August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

Sr. Verification and Validation Engineer

Detector Electronics LLC

Minneapolis, MN • On-site

$115K - $130K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 25 days ago

Job description

Sr. Verification & Validation Engineer
Job Description

About Us:

Det-Tronics is a $200M global technology leader in industrial life safety solutions, specializing in high-end flame and gas detection and automation control systems. As part of Spectrum Safety Solutions with 1,700 employees across 20+ countries we serve mission-critical environments in oil & gas, clean energy, marine, and infrastructure. Backed by Sentinel Capital Partners, we’re driving innovation and growth across our portfolio.

The Opportunity

The Verification and Validation Engineer supports the Verification and Validation (V&V) activities of New Product Development (NPD) and Sustaining projects by reviewing Requirements, developing Test Cases, linking Test Cases to Requirements, developing Test Plans and Test Executions, executing tests, and generating Coverage and Traceability Reports. The Verification and Validation Engineer also supports the design and development of tests, test fixtures, and test automation. The Verification and Validation Engineer is part of the Det-Tronics Engineering Test & Approvals Team. This role will perform detailed product analysis and hands-on product testing to verify and validate System and Customer Requirements.

Key Responsibilities:

  • Review Requirements for completeness (clarity, testability, and proper linkage to Test Cases) and provide input to other stakeholders including Design Engineers and Product Managers.
  • Work with product development teams to ensure Sub-System Requirements traceability and Test Case coverage.
  • Understand Customer and System Requirements and develop corresponding verification and validation Test Cases with proper linkage.
  • Create Test Plans and Test Executions using different tools including Jira.
  • Perform hands-on product testing by executing Test Cases, capturing and document test results and writing test reports.
  • Generate Coverage and Traceability Reports in tools such as Jira to track progress in Requirement traceability, test case coverage and overall testing progress.
  • Support the design and development of tests, test fixtures, and test automation. Maintain existing certifications, and support preparations for audits and participate in audits.
  • Develop optimized design V&V and regression test plans based on risk assessments.
  • Participate in process document reviews and editing to check their validity.
  • Support internal test capability development efforts.
  • Support root-cause investigations and activities for customer complaints and field issues.
  • Provide guidance and mentorship to entry-level technicians and engineers as needed.
  • Prioritize and manage work requests in an organized and timely manner.

What You Bring

Required Qualifications:

  • Bachelor’s degree in engineering.
  • At least 5 years of experience in testing electromechanical products.

Preferred Qualifications:

  • Bachelor’s degree (Electrical Engineering or Physics Highly preferred).
  • Experience with sustaining and new product development projects, and strong working knowledge of product development processes particularly verification and validation testing.
  • Understand requirements in safety and performance standards and apply that knowledge in the evaluation of a product via technical analysis and/or testing.
  • Follow department operating procedures and have an open attitude for continuous improvement.
  • Excellent written and verbal communication skills in order to clearly present data and articulate test results.
  • Good organizational skills and the ability to manage multiple projects at once.
  • Perform essential job functions safely, and work within established company guidelines.
  • Experience in requirement, test, and issue management tools such as R4J, Xray, and Jira.

Why Join Us?

  • Work with a globally respected brand in life safety
  • Influence strategic decisions at the executive level
  • Drive innovation and transformation in a high-growth environment
  • Enjoy development opportunities within a dynamic, private equity-backed company

Benefits:

At Det-Tronics, we believe in taking care of our people. Our comprehensive benefits package includes:

  • Health & Wellness: Medical, dental, and vision insurance plans with company contributions
  • Financial Security: 401(k) retirement plan with company match, life and disability insurance
  • Time Off: Generous paid time off (PTO), holidays, and flexible scheduling options
  • Professional Growth: Career development programs, training opportunities, and tuition reimbursement
  • Employee Support: Employee Assistance Program (EAP), wellness resources, and global mobility support
  • Ownership Culture: Participation in our Ownership Program, empowering employees to share in our success

Ready to shape the future of industrial safety?

Apply now and join us in making every life safe and sound.