Test Engineer I (Medical Devices)

TL;DR

Test Engineer I (Medical Devices): Designing and implementing testing methods for mechanical, electro-mechanical, and software medical products with an accent on verification and validation. Focus on automated testing, fixture design, and ensuring compliance with quality and reliability standards.

Location: Must be based in Lafayette, Colorado, USA (working onsite 4 days a week)

Salary: $70,400 - $105,600

Company

Global healthcare technology leader specializing in neuroscience, spinal implants, and robotic guidance systems.

What you will do

• Design, develop, and implement testing methods and equipment, including the design of tools, fixtures, and phantoms.
• Perform verification and validation of new or changed products, generating comprehensive plans, protocols, and reports.
• Create, develop, and maintain test software and implement automated testing frameworks.
• Troubleshoot, debug, and support existing products while participating in risk assessments and defect tracking.
• Collaborate with project teams and stakeholders to communicate technical findings and solutions.
• Ensure all activities comply with the Quality System and environmental, health, and safety regulations.

Requirements

• Bachelor's degree in a STEM field.
• Unrestricted U.S. work authorization required (sponsorship is not available for this level).
• Must be able to work onsite 4 days a week in Lafayette, CO.
• Ability to travel 10-20% for project collaboration and successful completion.

Nice to have

• Experience with C++, Python, Linux, SQL, Selenium, or Javascript.
• Knowledge of FDA Quality System Regulations (QSR) and medical device testing.
• Proficiency with generative AI tools (e.g., ChatGPT, Copilot) for scripting and documentation.
• Experience with Agile/iterative development and project management skills.
• Machine shop experience and knowledge of statistical methods.

Culture & Benefits

• Comprehensive health, dental, and vision insurance, including HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and life insurance.
• Tuition assistance/reimbursement and global well-being program (Simple Steps).
• Employee Stock Purchase Plan and short-term incentive plan (MIP).