ZipRecruiter

Log In

1

Medical Device Validation Engineer Jobs in Colorado

iMPact Business Group

Be Seen First

Test Engineer (Medical Devices)- 27607

Greenwood Village, CO · On-site

$50/hr

Performing engineering work in operations, production, construction, or maintenance environments ... Prior experience in medical device testing, quality assurance, or validation is highly desirable.

New

GILLIG

Validation Engineer

Loveland, CO · Hybrid

Excellent compensation including company paid medical premiums, generous retirement plan and other ... Validation Engineering is responsible for the testing, simulation, and evaluation of systems ...

GILLIG

Validation Engineer

Loveland, CO · On-site

Excellent compensation including company paid medical premiums, generous retirement plan and other ... Validation Engineering is responsible for the testing, simulation, and evaluation of systems ...

GILLIG

Validation Engineer

Loveland, CO · Hybrid

Excellent compensation including company paid medical premiums, generous retirement plan and other ... Validation Engineering is responsible for the testing, simulation, and evaluation of systems ...

Micron

Senior SSD Validation Engineer

Longmont, CO · On-site

$175K - $247K/yr

Recommend and instrument new validation approaches that drive better coverage, more accurate ... We offer a choice of medical, dental and vision plans in all locations enabling team members to ...

Three Point Solutions

Sr Process Engineer

Boulder, CO · On-site

$45 - $50/hr

Medical Device Manufacturing Company Duration: 2 Years (Possible Extension) Location: Boulder, CO ... Lead IQ, OQ, and PQ validation activities * Manage medium to large capital equipment projects

SwiftCruit

Staff Engineer, SSD Validation

Longmont, CO · On-site

$121 - $207/hr

As a Staff Engineer for SSD Validation, you will coordinate the validation, system integration, and ... We offer a choice of medical, dental and vision plans in all locations enabling team members to ...

next page

Showing results 1-20

All JobsMedical Device Validation Engineer JobsMedical Device Validation Engineer Jobs in Colorado

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 Colorado?

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

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

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

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

Cities in Colorado 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 Colorado as of June 2026, with employment types broken down into 70% Full Time, 26% Part Time, and 4% Contract. Highlights an 87% Physical, 4% Hybrid, and 9% Remote job distribution.

Test Engineer (Medical Devices)- 27607

iMPact Business Group

Greenwood Village, CO • On-site

$50/hr

Contractor

Medical, Dental, Vision

Posted 3 days ago

New

Be Seen First

After you apply to this job, you can share why you’re interested to jump to the top of the candidate list.

Job description

Our client, a Global Medical Device Manufacture, has an immediate opening for a Medical Device Test Engineer for an 18 Month + Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.

Job Duties

  • Performing engineering work in operations, production, construction, or maintenance environments.
  • Designing and scaling up manufacturing processes, instruments, and equipment, while testing manufactured products to maintain quality.
  • Planning, designing, and estimating time and cost, and overseeing the construction and maintenance of structures, facilities, systems, and components.
  • Analyzing and developing solutions to engineering problems related to manufacturing equipment and systems or the causes of component failures.
  • Developing and applying engineering standards and procedures, and providing advice on issues within the engineering field.


Requirements

  • Bachelor's degree in Engineering, Biomedical, or similar field.
  • Prior experience in medical device testing, quality assurance, or validation is highly desirable.
  • Strong analytical and troubleshooting abilities.
  • Ability to design and execute complex tests for medical devices.
  • Knowledge of quality assurance and validation processes in a regulated environment.
  • Experience with ISO 13485, FDA regulations, or medical device validation.
  • Familiarity with orthopedic or sports medicine device testing.
  • Manufacturing process development or equipment troubleshooting.