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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 ...

PSC Biotech

Validation Engineer

Minneapolis, MN

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 ...

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 ...

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 ...

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 August 2026, with employment types broken down into 69% Full Time, 5% Temporary, and 26% Contract. Highlights an 95% In-person, and 5% Remote job distribution.

Computer Systems Validation Engineer

Three Point Solutions, Inc.

Maple Grove, MN • On-site

Contractor

Re-posted 15 days ago

Job description

Job Title: Computer Systems Validation Engineer
Client: Medical Device Manufacturing Company
Location: Maple Grove, MN 55311
Duration: 6 Months Contract
Focus Area: FDA-regulated Medical Device Software/Systems Validation
Position Overview
The Computer Systems Validation Engineer will be responsible for validating software and equipment in compliance with FDA regulations and company policies. This role will ensure that systems meet strict quality, compliance, and documentation standards. The ideal candidate will have strong technical expertise in validation processes, SDLC, and regulatory compliance, with experience in medical device manufacturing.
Key Responsibilities
  • Define, develop, and maintain comprehensive specifications for equipment/software (e.g., PLCs, Visual Basic apps, databases, SCADA applications, FDA-regulated systems).
  • Develop and review validation/qualification protocols, ensuring compliance with FDA requirements and QSR regulations.
  • Execute validation and qualification protocols, record results, and manage documentation via Change Requests.
  • Provide project estimates independently and review estimates for junior engineers.
  • Perform project lead activities on small to large-scale validation/qualification projects.
  • Ensure consistency and quality of validation work through peer reviews, mentoring, and training of Engineer I's and II's.
  • Support audits and regulatory inspections by providing accurate documentation and validation evidence.
  • Drive compliance with 21 CFR Part 11 (electronic records/e-signatures) and other FDA guidelines.
  • Influence cross-functional engineering initiatives and contribute to defining departmental best practices.

Required Qualifications
  • Bachelor's Degree in an Engineering discipline.
  • 5-9 years of direct experience in software/equipment validation within a regulated environment.
  • Strong background in medical device manufacturing and compliance documentation.
  • Hands-on experience with SDLC (System Development Life Cycle).
  • Excellent organizational, verbal, and written communication skills.
  • Proficiency in MS Office tools.
  • Ability to manage multiple priorities, with high attention to detail.
  • Strong interpersonal skills and a collaborative, team-oriented mindset.

Preferred Qualifications
  • Prior experience in an FDA-regulated industry.
  • Experience supporting audits and working with regulatory bodies.
  • Prior quality role experience ensuring compliance with industry standards.
  • Practical knowledge of 21 CFR Part 11 (electronic records/electronic signatures).

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