Sr Quality Engineer - Exempt

Join our dynamic team in Lafayette, CO, where you will have the opportunity to work at the forefront of medical device innovation. Our location offers a vibrant community and easy access to the beautiful Colorado outdoors, providing a perfect balance of professional growth and personal well-being.

As a design quality engineer, you will collaborate with a cross-functional team to develop new products or enhance existing products for the Acute Care & Monitoring business. You will ensure that our products meet the highest quality standards by reviewing user and system requirements, design documentation, test plans, test protocols, test reports, and deliverables per the development procedures.

Responsibilities

• Work collaboratively with cross-functional teams to drive project execution for medical devices, prioritizing safety, quality service, and on-time execution.
• Lead teams to define goals, provide solutions, and align on path forward, driving, tracking, and communicating progress.
• Review FMEAs and security evaluations, transferring those risks into risk management files for the product under development.
• Develop, modify, apply, and maintain quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Conduct quality assurance tests and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensure corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

Must Have

• Experience in medical device design, development, and manufacturing, with products that have electrical functionality.
• Examples of critical thinking and proven project execution.
• Experience leading cross-functional teams and leveraging solid project management skills, including project planning, communication, and risk management.
• Understanding of systems engineering – requirements flow from user needs to system requirements to subsystem requirements.
• Understanding of Risk Management standard: ISO 14971 and how to apply it to hardware and software (IEC TR 80002-1).
• Familiarity with medical devices standards for electrical safety (IEC 60601), software (IEC 62304), and biocompatibility/sterilization (ISO 10993).

Nice to Have

• 2 years of product development experience.
• Intimate knowledge of Risk Management.

Education and Experience

• Bachelor’s degree in an engineering discipline.
• Up to 8 years of relevant experience.

Work Schedule

This position requires the candidate to be onsite at least 4 days per week, working 40 hours a week.

Interview Timeline

We are looking to schedule interviews as soon as possible.