Sr. Product Engineer
REQUIREMENTS:
Requires a Masters’ degree in Biomedical, Electrical, Mechanical or closely related engineering field and 1 year of experience with Product or Supplier Quality Engineering and one (1) year of post-bachelor’s progressive experience in all of the following: DRM (Design, Reliability and Manufacturing) Tools and methodology within new product development programs; Component and Product Qualifications, Interpret GD&T (Geometric Dimensioning and Tolerancing), Test Method Validations (Gage Repeatability & Reproducibility); Process Validations (Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)); Statistical Data Analysis and decision making; Supplier controls, supplier auditing, statistical quality control, protocol & report preparation, non-conforming product controls, Control Plans, Risk activities to include DFMEA and PFMEA; ISO13485, ISO9001, ISO 14971 and FDA CFR 21 part 820; Good Manufacturing Practices in medical device environment.
