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Medical Device Validation Engineer Jobs in Colorado

Validation Engineer

Aurora, CO ยท Hybrid

$45 - $55/hr

Validation Engineer Support validation activities for approximately 30 heat sealing assets and ... Medical device equipment knowledge. * Sterile processing experience. Additional Skills ...

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

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

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

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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 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:

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.

Validation Engineer

Actalent

Aurora, CO โ€ข Hybrid

$45 - $55/hr

Contractor

Medical, Dental, Vision, Life, Retirement, PTO

Posted 21 days ago


Job description

Job Title: Validation EngineerJob Description

Support validation activities for approximately 30 heat sealing assets and packaging projects. Execute established validation protocols and procedures without the need for process development. Perform testing, collect data, and document results. Generate validation reports using existing templates and ensure packaging meets seal strength and quality requirements. Coordinate equipment scheduling with operations and asset teams, partnering with packaging and validation teams to keep projects on schedule. Take ownership of day-to-day validation execution to help free up internal resources.

Responsibilities
  • Support validation activities for heat sealing assets and packaging projects.
  • Execute validation protocols and procedures.
  • Perform testing and collect data for documentation.
  • Generate validation reports using existing templates.
  • Ensure packaging meets seal strength and quality requirements.
  • Coordinate equipment scheduling with operations and asset teams.
  • Partner with packaging and validation teams to maintain project schedules.
  • Own day-to-day validation execution to free up internal resources.
Essential Skills
  • Experience in packaging validation.
  • Equipment validation expertise.
  • Proficiency in IQ/OQ/PQ validation processes.
  • Technical writing skills.
  • Tensile testing experience.
  • Medical device equipment knowledge.
  • Sterile processing experience.
Additional Skills & Qualifications
  • Medical device experience.
  • Experience with heat sealing equipment.
  • Experience in sterile barrier packaging.
  • Experience in training technicians or other personnel.
Work Environment

Hybrid work environment with a minimum of three days onsite. The role operates within a manufacturing and packaging environment. Report writing may be completed remotely. Enjoy a flexible and meaningful work setting with high visibility projects.

Job Type & Location

This is a Contract position based out of Centennial, CO.

Pay and Benefits

The pay range for this position is $45.00 - $55.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Centennial,CO.

Application Deadline

This position is anticipated to close on Aug 25, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.


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About Actalent

Sourced by ZipRecruiter

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

Company size

5,001 - 10,000 Employees

Headquarters location

Hanover, MD, US

Year founded

1983

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