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Validation Engineer Biomedical Jobs in Colorado (NOW HIRING)

Stryker

Senior Product Engineer

Denver, CO · On-site

$85K - $142K/yr

... product validation activities * Partner with suppliers to establish and sustain manufacturing ... Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field * Minimum 2+ ...

Stryker

Senior Product Engineer

Denver, CO · On-site

$85K - $142K/yr

... product validation activities * Partner with suppliers to establish and sustain manufacturing ... Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field * Minimum 2+ ...

System One

R&D Test Engineer

Greenwood Village, CO · On-site

Verify fixtures and qualify test methods used for verification and validation * Generate ... S.) in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or related ...

System One

R&D Test Engineer

Greenwood Village, CO · On-site

Verify fixtures and qualify test methods used for verification and validation * Generate ... S.) in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or related ...

System One

R&D Test Engineer

Greenwood Village, CO · On-site

Verify fixtures and qualify test methods used for verification and validation * Generate ... S.) in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or related ...

Hologic

Human Factors Engineer 4

Louisville, CO · On-site

SME for Design Controls, Design Validation, and quality risk management within a regulated QMS ... Engineering, Biomedical Engineering, Systems Engineering or related field. Advanced degree ...

New

Hologic Inc.

Human Factors Engineer 4

Louisville, CO · Hybrid

SME for Design Controls, Design Validation, and quality risk management within a regulated QMS ... Engineering, Biomedical Engineering, Systems Engineering or related field. Advanced degree ...

New

Terumo BCT, Inc.

Engineer 2 - Human Factors

Lakewood, CO · On-site

... formal validation testing. * Ensures that product development projects are following HFE process ... Bachelor of Science Degree in Usability/Human Factors Engineering, Biomedical Engineering, Systems ...

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All JobsValidation Engineer Biomedical JobsValidation Engineer Biomedical Jobs in Colorado

Validation Engineer Biomedical information

What does a validation engineer do in biomedical?

A Validation Engineer in the biomedical industry ensures that equipment, processes, and systems used in the production of medical devices or pharmaceuticals meet regulatory standards and function as intended. Their work involves planning and executing validation protocols, documenting results, and troubleshooting any deviations. This role is crucial for maintaining product quality, patient safety, and compliance with regulatory agencies such as the FDA. Validation Engineers often collaborate with quality assurance, manufacturing, and research teams to establish and maintain validated systems throughout a product's lifecycle.

What are the key skills and qualifications needed to thrive as a validation engineer in biomedical?

To thrive as a Validation Engineer in Biomedical, you need a solid background in engineering or life sciences, knowledge of regulatory standards (such as FDA or ISO 13485), and experience with validation protocols. Familiarity with technical tools like statistical analysis software, calibration equipment, and documentation systems is essential, and certifications such as Six Sigma or CQE can be advantageous. Strong problem-solving, attention to detail, and effective communication skills help you excel in cross-functional teams and ensure compliance. These skills are crucial for maintaining product quality, meeting regulatory requirements, and ensuring patient safety in biomedical environments.

What are some typical challenges faced by validation engineers in the biomedical industry and how can they be addressed?

Validation Engineers in the biomedical field often face challenges such as keeping up with evolving regulatory requirements, managing complex documentation, and ensuring equipment or processes meet stringent quality standards. Navigating audits and working cross-functionally with R&D, manufacturing, and quality assurance teams can also be demanding. To address these challenges, staying current with industry regulations, developing strong organizational and communication skills, and maintaining meticulous records are essential for success and career growth in this role.

What is the difference between Validation Engineer Biomedical vs Quality Assurance Engineer Biomedical?

AspectValidation Engineer BiomedicalQuality Assurance Engineer Biomedical
CertificationsGMP, ISO, FDA validation certificationsGMP, ISO, audit and compliance certifications
Work EnvironmentDesign, develop, and execute validation protocols for medical devicesDevelop and maintain quality systems, audits, and process improvements
Industry UsagePrimarily in medical device manufacturing and regulatory validationAcross medical device, pharmaceutical, and biotech industries

Validation Engineer Biomedical focuses on ensuring medical devices meet regulatory validation requirements through testing and protocols. Quality Assurance Engineer Biomedical emphasizes maintaining quality systems, compliance, and process improvements. Both roles are essential in the biomedical industry but serve different functions related to validation versus quality assurance.

What are popular job titles related to Validation Engineer Biomedical jobs in Colorado?

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

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

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

What cities in Colorado are hiring for Validation Engineer Biomedical jobs?

Cities in Colorado with the most Validation Engineer Biomedical job openings:

Validation Engineer Biomedical jobs near you
Infographic showing various Validation Engineer Biomedical job openings in Colorado as of June 2026, with employment types broken down into 91% Full Time, 5% Part Time, and 4% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution.

Senior Product Engineer

Stryker

Denver, CO • On-site

$85K - $142K/yr

Full-time

Re-posted 3 days ago

Stryker rating

8.2

Company rating: 8.2 out of 10

Based on 112 frontline employees who took The Breakroom Quiz

134th of 499 rated machine equipment manufacturers

Job description

Work Flexibility: Onsite
Stryker is hiring a Senior Product Engineer, in Greenwood Village, CO to lead sustaining engineering efforts across our Sports Medicine product portfolio. This role focuses on driving design changes to existing commercial products to improve performance, safety, compliance, and cost, with a strong emphasis on maintaining supply continuity. You will assess the product impact of supplier, material, and manufacturing changes while supporting product improvements, line extensions, remediation activities, and supply continuity initiatives throughout the product lifecycle.
What you will do
  • Support design and process changes for commercial products to improve performance, reliability, compliance, and cost
  • Assess and implement material changes, supplier updates, and manufacturing transfers, ensuring product design requirements and performance expectations are maintained.
  • Analyze product and process issues, determine root causes, and implement corrective actions
  • Author, review, and maintain engineering documentation, including design history files and technical reports
  • Apply applicable regulations and standards to design controls, risk management, and product validation activities
  • Partner with suppliers to establish and sustain manufacturing processes and product capabilities
  • Collaborate with cross-functional teams to implement product changes into production and mitigate associated risks

What you will need
Required qualifications
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field
  • Minimum 2+ years of experience in sustaining engineering, product development, product engineering, or manufacturing within a regulated environment.

Preferred qualifications
  • Experience leading product design changes for commercialized products
  • Experience supporting product design changes related to manufacturing processes, supplier changes, or product lifecycle management activities.
  • Experience evaluating supplier, material, and manufacturing changes for design impact
  • Experience with electromechanical or mechanical product design
  • Experience creating engineering drawings using GD&T principles
  • Experience using CAD tools (e.g., SolidWorks)

US10: $85,500 - $142,500 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Travel Percentage: 20%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

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