ZipRecruiter

Log In

1

Validation Engineer Biomedical Jobs in Colorado (NOW HIRING)

Excelitas Technologies

Industrial Engineer

Boulder, CO

$90K - $117K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

... biomedical, semiconductor, industrial, consumer products, scientific, security, defense and ... Develop, maintain, and validate site capacity models and cycle-time standards to identify and ...

New

Excelitas Technologies

Automation Engineer/Sr

Boulder, CO

$140K - $170K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

... biomedical, semiconductor, industrial, consumer products, scientific, security, defense and ... Participate in equipment commissioning, system validation, and startup activities. * Ensure ...

New

CONMED

Mechanical Engineer III - Advanced Surgical

Englewood, CO · Hybrid

$82K - $125K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Conduct verification and validation testing. * Engage with customers to gain a deep understanding ... S. in Mechanical, Biomedical Engineering, or highly related field required * 5 years related ...

Excelitas Technologies

Senior Cost Accountant

Boulder, CO · On-site

$111K - $130K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

... biomedical, semiconductor, industrial, consumer products, scientific, security, defense and ... Identify and validate Continuous Improvement (CI) and Savings initiatives in collaboration with ...

Gehc

Field Engineer Apprentice

Denver, CO · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Must have reliable transportation and a valid driver's license. * Legal authorization to work in ... biomedical or electronic equipment. * Analytical and communication skills with the ability to ...

previous page

Showing results 41-60

All JobsValidation Engineer Biomedical JobsValidation Engineer Biomedical Jobs in Colorado

Validation Engineer Biomedical information

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 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 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 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 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.

Sr. Manufacturing/Process Engineer

Trisalus Life Sciences, Inc.

Westminster, CO • On-site

$115K - $125K/yr

Full-time

Re-posted 17 days ago

Job description

Duties and Responsibilities:

  • Lead the development, validation, and continuous improvement of manufacturing and process technologies for medical device products in accordance with FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
  • Serve as a senior technical resource for manufacturing and process engineering activities across multiple product lines.
  • Lead complex, cross-functional projects from concept through commercialization, including new product introductions, line extensions, and transfers from R&D to manufacturing.
  • Develop, qualify, and validate new manufacturing processes and equipment, including authorship and execution of IQ/OQ/PQ protocols, test method validations (TMV), and process validation reports.
  • Create and maintain the process validation master plan.
  • Apply statistical methods including Design of Experiments (DOE), Statistical Process Control (SPC), Measurement System Analysis (MSA/Gage R&R), and process capability analysis to develop, characterize, troubleshoot, and control manufacturing processes.
  • Lead risk management activities for manufacturing processes, including authorship and review of PFMEAs.
  • Drive Design for Manufacturability (DFM) input during product development and design transfer activities.
  • Identify, evaluate, and implement opportunities to reduce cycle time, scrap, and manufacturing cost; develop and execute plans to capitalize on these opportunities.
  • Apply Lean manufacturing principles and continuous improvement methodologies to optimize production workflows, layouts, and equipment utilization.
  • Lead the evaluation, specification, design, and qualification of tools, fixtures, custom equipment, and production systems to meet capability and capacity requirements.
  • Monitor process output, yield, and scrap; analyze trends and drive corrective actions to improve performance.
  • Perform and oversee cleanroom (Class 8) validations as required.
  • Manage activities with outside vendors and contract manufacturers providing components, assemblies, processes, testing, and other services.
  • Lead investigations of nonconformances and support CAPA activities, including root cause analysis and effectiveness checks.
  • Author, review, and approve standard operating procedures, work instructions, engineering change orders, and related quality system documentation.
  • Train production operators and technicians on new processes and ensure adherence to process standards.
  • Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations and ISO 13485.
  • May supervise and provide technical direction to engineers, technicians, and operators; mentor junior engineers and technicians.
  • Present project status, technical findings, and recommendations to cross-functional teams and management.
  • Maintain effective communications with supervisor, peers, and stakeholders.
  • Provide strategic direction for specific projects and contribute to departmental planning.
  • Support day-to-day manufacturing activities as needed.

Qualifications

Education & Certifications:

  • Minimum of BS in Mechanical, Biomedical Engineering or directly related scientific discipline.

Work Experience:

  • Minimum of 10 years' experience in a medical device manufacturing environment is required.
  • FDA regulated work experience required.
  • Demonstrated experience leading process validations (IQ/OQ/PQ) and manufacturing process development require

Knowledge, Skills & Abilities:

  • Able to read, write and understand English.
  • Strong working knowledge of FDA 21 CFR Part 820 and ISO 13485.
  • Proficiency in statistical methods including DOE, SPC, MSA, and process capability analysis.
  • Working knowledge of design controls, risk management, and CAPA processes.
  • Familiarity with Lean manufacturing and continuous improvement methodologies.
  • Strong project management and technical leadership skills.

Physical Requirements:

  • Able to work in both office and industrial/cleanroom environments