Take an effective and proactive leadership role in a specific technical manufacturing discipline.
Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks that may have multiple inter-coordinating elements.
Anticipate and identify key issues and make recommendations for resolution where precedent may not exist and creative thinking is required.
Resolution may involve the application of new methods and approaches and may require the consideration of impact with other system components.
Interaction with peers and mentors on the individual's projects is generally in the context of peer review to confirm the rationale for task approach direction and peer review of verification/validation activities.
Bachelors of Science or Bachelors of Engineering in Electrical, Software, or Mechanical Engineering.
A minimum of 6 years experience in an engineering discipline or advanced education to achieve the level of skill.
Demonstrated EU-MDR experience
Ability to work with a cross functional team
Conformable with documentation work
Ability to work with teams
Process validation skills
Familiar with IQ/OQ/PQ
Medical device experience required
2-3 years of experience with EUMDR or Medical device and process validation experience