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Sr Biomedical Engineer Jobs in Colorado (NOW HIRING)

UCHealth

Biomedical Equipment Tech Sr

Steamboat Springs, CO · On-site

$37.04 - $55.57/hr

YVMC Clinical Engineering Work Schedule: Full Time, 80.00 hours per pay period (2 weeks) Shift ... Certified Biomedical Equipment Technician, or Certified Laboratory Equipment Specialist. * 5 years ...

CONMED

Senior Manager, Regulatory Affairs

Englewood, CO · On-site

Bachelor's degree in science, biomedical engineering, engineering, regulatory affairs, or a related technical discipline. * Minimum 8 years of directly relevant Regulatory Affairs experience in the ...

Medtronic

Sr. Engineering Manager

Lafayette, CO · On-site

$215K - $256K/yr

Bachelors' Degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and six (6) years of progressive post-baccalaureate experience as a manufacturing or analyst ...

Medtronic

Sr. Engineering Manager

Lafayette, CO

$215K - $256K/yr

Bachelors' Degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and six (6) years of progressive post-baccalaureate experience as a manufacturing or analyst ...

Medtronic

Sr. Engineering Manager

Lafayette, CO · On-site

$215K - $256K/yr

Bachelors' Degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and six (6) years of progressive post-baccalaureate experience as a manufacturing or analyst ...

System One

R&D Test Engineer

Greenwood Village, CO · On-site

Can identify and escalate blockers and technical challenges to senior project team members as ... S.) in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or related ...

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Sr Biomedical Engineer information

What does a Sr Biomedical Engineer do?

A Sr Biomedical Engineer is responsible for designing, developing, and improving medical devices and equipment used in healthcare. They work closely with doctors, nurses, and other medical professionals to ensure that devices meet clinical needs and comply with safety regulations. Senior-level biomedical engineers often lead project teams, oversee testing and validation, and contribute to product innovation. They may also mentor junior engineers and collaborate with regulatory bodies to ensure products meet industry standards.

What are the key skills and qualifications needed to thrive as a Sr Biomedical Engineer?

To excel as a Sr Biomedical Engineer, you need a deep understanding of biomedical engineering principles, advanced problem-solving abilities, and a relevant degree such as a BS or MS in biomedical engineering or related fields. Familiarity with CAD software, medical device regulatory standards (like FDA or ISO 13485), and experience with validation and testing tools are typically required. Exceptional project management, teamwork, and communication skills help in leading projects and collaborating across multidisciplinary teams. These competencies are vital for ensuring innovative, safe, and effective medical solutions that meet regulatory standards and patient needs.

How does a Sr Biomedical Engineer typically collaborate with cross-functional teams in the development of medical devices?

As a Sr Biomedical Engineer, you will regularly work with multidisciplinary teams that may include clinicians, mechanical engineers, electrical engineers, regulatory specialists, and quality assurance professionals. Collaboration often involves participating in design reviews, integrating clinical feedback into prototypes, and ensuring compliance with regulatory standards. Effective communication and project management are key, as you will help align technical requirements with user needs and business goals. This dynamic teamwork fosters innovation while ensuring the safety and efficacy of medical devices.

What is the difference between Sr Biomedical Engineer vs Biomedical Equipment Technician?

AspectSr Biomedical EngineerBiomedical Equipment Technician
CredentialsBachelor's or Master's in Biomedical Engineering, certifications like CBETAssociate's degree or certification in biomedical technology
Work EnvironmentDesign, develop, and oversee biomedical devices; collaborate with R&D teamsMaintain, repair, and calibrate medical equipment in hospitals or clinics
Industry UsageUsed in medical device companies, hospitals, research institutionsPrimarily in healthcare facilities for equipment servicing

While both roles work with medical devices, Sr Biomedical Engineers focus on design, development, and system integration, whereas Biomedical Equipment Technicians handle maintenance and repairs. The roles complement each other in ensuring medical equipment functions safely and effectively.

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

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

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

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

Sr Biomedical Engineer jobs near you
Infographic showing various Sr Biomedical Engineer job openings in Colorado as of August 2026, with employment types broken down into 88% Full Time, 9% Part Time, and 3% Contract. Highlights an 86% Physical, 5% Hybrid, and 9% Remote job distribution.

Sr. Manufacturing/Process Engineer

Trisalus Life Sciences, Inc.

Westminster, CO • On-site

$109K - $141K/yr

Full-time

Re-posted 4 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

Apply