Contract position: Medical device company is currently looking for a Principal Engineer in Round Lake IL. Ideal candidate will have test method validation experience working on remediation projects. This is a contract position expected to last 12 months, could be longer based on performance, possible temp to perm. Currently we are only looking for local candidates. Great Contractor Benefits! Apply Now!
Responsibilities for the Principal Engineer
- Lead a major component of the overall DHF remediation initiative. This may include one or more of the following: Design Verification, Test Method Development and Validation, Risk Management, Design Validation, and Labeling Remediation.
- Develop design verification test methods and test fixtures. Work with lab technicians and the Product Design Owner to confirm that test methods and fixtures are appropriate
- Lead individual test method validation (TMV) studies. Author TMV studies, establish pre-defined acceptance criteria, serve as study director, proctor TMV data collection, perform statistical analyses on results, and author study reports
- Lead design verification studies. Author verification studies, establish pre-defined acceptance criteria, serve as study director, perform statistical analyses on results, and author study reports
- Lead investigations into TMV and/or design verification study failures. Provide recommendations on how to proceed through failure resolution, and escalate issues to management appropriately. Recommend improvements to test methods.
Requirements for the Principal Engineer
- BS engineering (Mechanical or Biomedical Engineering preferred)
- 5+ years medical device remediation and validation experience
- Must have experience developing test methods, test fixtures, and conducting design verification studies
- Familiarity with medical device design control methodologies and design history file formation
- Solutions container experience is preferred