- Systems or Quality engineer whose primary responsibilities will involve conducting the activities associated with the demonstration of compliance to applicable regulatory standards for Medical electrical equipment. These responsibilities will include compliance with the applicable processes associated with the development, release, and maintenance of these medical devices.
- Identification of applicable standards, processes, and procedures required for the development, maintenance, and global marketing of medium to high complexity medical electrical equipment.
- Clause-by-clause analysis of applicable standards, including the generation of rationale for non-applicable clauses
- System, sub-system, process, procedure, and documentation requirements audit and generation as they relate to activities conducted in the demonstration of compliance to the applicable standards
- Develop and document the protocols, processes, and procedures required for self-certification activities as well as design confidence testing intended to demonstrate compliance to applicable standards
- Execute the testing activities required to demonstrate compliance to applicable standards
- Execute failure analysis activities in response to non-compliances
- Participate in solution discovery in response to non-compliances
- Generate NRTL input documentation and materials
- Project management and support for NRTL activities
- Generate status updates, schedules, deliverable lists, and formal reports as required during the execution of the agency compliance effort
- Communicate directly with leadership for project updates
- Manage the efforts of a small team of technicians and/or engineers supporting agency compliance activities
- Collaborate across disciplines and functions to find solutions & methods to complete assignments
- Minimum of an associate’s degree in a related technical field with 5+ years’ experience required. BS EE/ME/CS with 2+ years of systems engineering or similar experience desired
- Experience with the entire agency compliance process from requirements generation to agency certification for at least one IEC 60601-1 3rd edition medical device required
- Experience with IEC 60601-1 2nd edition as well as edition 3.1 highly desirable
- Experience with the entire agency compliance process from requirements generation to agency certification for at least one IEC 60601-1-2 3rd edition medical device required
- Experience with IEC 60601-1-2 4th edition highly desirable
- Experience with the application of ISO14971 based risk management systems, processes, and activities required
- Experience with IEC 62366 and IEC 62304 highly desirable
- Strong technical writing skills required
- Experience with Agile PLM, DOORs, JIRA, and/or Polarion desired
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