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Validation Engineer Biomedical Jobs in Colorado (NOW HIRING)

Senior Product Engineer

Denver, CO · On-site

$86 - $143/hr

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

Documentation & Validation • Prepare and maintain engineering documentation, including protocols ... Manufacturing Engineering, Industrial Engineering, Biomedical Engineering, Mechanical Engineering ...

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+ ...

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+ ...

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

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

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

Defines and executes verification and validation activities with support from testing and quality ... Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering ...

... validation activities with support from testing and quality teams. • Designs components for ... Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering ...

Showing results 21-40

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:

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 Group

Denver, CO • On-site

$86 - $143/hr

Other

Re-posted just now


Job description

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)

Posted Date: 08/05/2026 This role will be posted for a minimum of 3 days.


US10: $85,500 - $142,500 USD Annual

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