Engineering Technician

TriSalus Life Sciences; Westminster (CO); On-site; USD 45,000 - 70,000; Full time

Job summary

TriSalus Life Sciences in Westminster, CO, is seeking a dedicated technician to support the engineering team in the development of catheter-based medical devices and improvement of manufacturing processes in compliance with FDA and ISO 13485.

You will perform hands-on lab and manufacturing tasks, assemble prototypes, run tests with standard equipment, and help maintain R&D systems, contributing to quality and safety.

Qualifications

• Experience in lab or medical device manufacturing environments.
• Familiarity with ISO 13485 and 21 CFR 820 preferred.
• Ability to read and interpret engineering drawings.
• Basic SolidWorks knowledge preferred.

Responsibilities

• Support engineering in development of catheter-based medical devices.
• Assist manufacturing improvements under FDA/ISO guidance.
• Assemble medical device prototypes for evaluation and testing.
• Perform testing with standard lab and inspection equipment.
• Build tools and fixtures for manufacturing needs.
• Support installation, troubleshooting and maintenance of R&D equipment.
• Follow approved procedures and help update docs as needed.
• Ensure compliance with 21 CFR 820 and ISO 13485.
• Maintain safety and clear communication with the team.

Skills

Physical & mechanical testing

Engineering drawings interpretation

Independent work

Lab/manufacturing support

Education

High school diploma or GED

Tools

SolidWorks

Job description

Duties and Responsibilities

Support the engineering team in development of new catheter-based medical devices and improvement of manufacturing processes in accordance with FDA and international regulations.

• Support day-to-day engineering activities including hands on laboratory and manufacturing support.
• Assemble medical device prototypes for product evaluation and testing.
• Perform testing using standard laboratory and inspection equipment (e.g. force testers, calipers, flow models, gauges, etc.)
• Build tools and fixtures utilizing experience with common shop tools.
• Support installation, troubleshooting, and maintenance of R&D equipment.
• Execute work according to approved procedures and provide feedback to update or generate new procedures as needed.
• Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations (21 CFR 820) and ISO 13485 requirements.
• Assure individual and group safety when conducting all activities.
• Maintain clear and effective communication with supervisors and cross-functional team members.

Education & Certifications

• High school diploma or GED required

Work Experience

• 1-3 years experience working in a lab or medical device manufacturing environment.

Knowledge, Skills & Abilities

• Experience with physical and mechanical testing. ISO and ASTM testing experience preferred.
• Ability to read and interpret engineering drawings.
• Basic knowledge/capability of SolidWorks is preferred.
• Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices

Physical Requirements

• Able to use a microscope and operate machinery.
• Must be able to lift and carry up to 40 lbs.