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Medical Device Validation Engineer Jobs in Minnesota

Forj Medical

Validation Engineer, Senior

Saint Paul, MN · On-site

$100K - $115K/yr

At Forj Medical, we work side by side with more than 100 medical device companies from startups to ... Job Summary The Validation Engineer is the architect and primary owner of the site-wide equipment ...

Collabera LLC

Validation Engineer

Saint Paul, MN · On-site

$45 - $50/hr

Validation Engineer * Location: St. Paul, MN (100% Onsite) * Pay Rate: $45 $50/hour * Employment ... medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance ...

Bracco

Medical Device Assembler I

Eden Prairie, MN · On-site

$18.25 - $22.50/hr

The Medical Device Assembler I is responsible for performing a variety of production tasks related ... Instructions (WI), Engineering Prints and Bills of Materials (BOM). Primary Duties ...

Bracco

Medical Device Assembler I

Eden Prairie, MN

$18.25 - $22.50/hr

The Medical Device Assembler I is responsible for performing a variety of production tasks related ... Instructions (WI), Engineering Prints and Bills of Materials (BOM). Primary Duties ...

PSC Biotech

Validation Engineer

Minneapolis, MN · On-site

The Validation Engineer will collaborate with cross-functional teams to support project execution ... Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for ...

PSC Biotech

Validation Engineer

Minneapolis, MN · On-site

The Validation Engineer will collaborate with cross-functional teams to support project execution ... Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for ...

PSC Biotech

Validation Engineer

Minneapolis, MN · On-site

$90K - $105K/yr

The Validation Engineer will collaborate with cross-functional teams to support project execution ... Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for ...

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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 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 July 2026, with employment types broken down into 78% Full Time, 15% Part Time, and 7% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.

Validation Engineer III

Intellectt INC

North Saint Paul, MN • On-site

Contractor

Re-posted 4 days ago

Job description

Hiring: Validation Engineer III
Location: St. Paul, MN
Type: W2 Contract
Industry: Medical Device
We are currently hiring for the position of Validation Engineer III with a leading Medical Device client. This role is ideal for candidates with experience in validation, quality systems, and regulated manufacturing.
 
Key Responsibilities:
• Prepare and execute validation protocols and related documentation.
• Review and analyze validation results and prepare final reports.
• Manage Validation Master Plans (VMPs) and validation activities.
• Support change management by assessing process, system, and document changes.
• Participate in internal and external quality audits.
• Work with cross-functional teams to ensure validation projects are completed on time.
 
Qualifications:
• Bachelor's degree in Engineering or a related technical field.
• 5+ years of validation engineering experience in a regulated industry.
• Experience with IQ/OQ/PQ, Test Method Validation, and Validation Master Plans (VMP).
• Knowledge of Quality Management Systems (QMS) and change control processes.
• Strong communication, documentation, and problem-solving skills.