Description
Specific responsibilities:- Review inspection / quality plans and determine impact to resources
- Research design features to determine risk to quality / function / patient
- Develop risk analysis of product features
- Research complaints and non-conformance material reports to develop historical data
- Update inspection sheets (Microsoft Word) and route through ECO process (Agile / Oracle)
- Present findings and make recommendations to engineering teams
Qualifications
- Bachelor of Science in the Engineering required, Mechanical or Biomedical preferred
- Medical device experience required - 5+ years
- Orthopedic experience, specifically in the total joint space - 3+ yrs
- Understanding of inspection techniques (gages, fixture, CMM, vision systems, etc)
- GD&T understanding, doesn't have to be an expert but needs to know what GD&T is and basic principles
- R&D experience preferred, but would take Operations / Manufacturing experience if it's in design control related activities (not looking for an ME)
- Experience with generating risk analysis documents, familiarity with ISO 14971 preferred
- Understanding of a medical device company's complaint process, FDA and ISO requirements on complaints
- Statistical analysis skills, specifically trending and analysis, pareto charts, rate calculations (events / shipments)
- Use of MiniTab a plus
- Office skills required, specifically Word, and excellent writing skills
- Solidworks experience a plus