Location: Colorado Springs CO
Duration: 6 Months
Knowledge of job related tools, processes, testing equipment, and catheter production equipment preferred. Demonstrated history of fast learning for job related tools, processes, equipment required
The ideal candidate is proficient in Word, Excel, Outlook, Solidworks, JMP or Minitab statistical software, Agile documentation management system, Maintenance Connection, and all other job related computer programs
Detail oriented, well organized, strong verbal and written communication skills
Self-motivated and creative
Typical experience required is 3+ years as an Engineer in a related field
Bachelors of Science degree in an engineering discipline, preferably in Mechanical Engineering but may also be Chemical, Electrical, or Materials Engineering degree; advanced degree is preferred
Preferred candidate will have effective working knowledge and experience with Project Management, Lean, Design for Six Sigma, Design for Manufacturing and Reliability (DRM), DOE, Process Control (SPC), process FMEA, validation/qualification, traceability, and process documentation.
Statistical analysis skill set is required. Experience with JMP or Minitab software is a plus.
A thorough understanding of process validation relating to medical device regulations is preferred
Knowledge of Process Validation, IQ, OQ, PQ, PPQ, Software validation, test method validation, gage R&R, and a clear understanding of FDA’s QSR and cGMP
Experience in Medical Device Industry is preferred
Familiarity with the Agile Project Management Scrum methodology a plus