Job Description
Position Description:
Principal R&D Engineer for Covidien, LP (a Medtronic company) .Responsible for supporting the design and development of products for the Surgical Supplies R&D organization from concept to commercialization. Generate solutions that are imaginative, thorough, practical, and consistent with organizational objectives. Provide engineering support for new product design and development including existing product modifications and process design, development and optimization and performance evaluation. Define requirements and system architecture for new product development for electromechanical medical devices. Develop and test prototypes from design specifications, defines processes to properly make and assemble the product and optimizes processes. Coordinate various programs which include FMEA (Failure mode and effect analysis) and Risk Assessments. Coordinate Process Validation, DOE (Design of Experiments), Gage R&R (Gage Repeatability & Reproducibility) and GD&T (Geometric Dimensioning and Tolerancing). Utilize various failure investigation techniques, statistical quality control, protocol & report preparation and non-conforming product controls. Navigate the complexities of government and industry regulations to include QSR (Quality Systems Regulation) 21 CFR 820, ISO 13485, ISO 9001, IEC 60601 and ISO 14971 (for product development in the medical device industry). Develop protocols including Design verification, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Special Process Validations, and Test Method Validations. Provide technical support for regulatory notifications and submissions using 510(k)s and PMAs for domestic and international approvals. Responsible for medical device Plastic & Sheet Metal Designing and manufacturing processes. Leverage Injection Molding Processes for plastics & metals. Performing Finite Element Analysis using Ansys and Dynamic mechanism model creations using Creo software for predicting structural and thermal failures virtually. Performing 1D and 3D tolerance studies using CE Tol for finding critical gaps between components in the medical devices. Relocation assistance is not available for this position. #LI-DNI
NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows:
Certifying Officer
U.S. Department of Labor
Employment and Training Administration
Office of Foreign Labor Certification
200 Constitution Avenue NW, Room N-5311
Washington, DC 20210
Basic Qualifications:
Requires a Masters’ Degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and five (5) years of experience as an R&D engineer or related occupation in manufacturing engineering. Must possess at least five (5) years’ experience with each of the following: Defining requirements and system architecture for electromechanical medical devices; Test prototypes from design specifications and defining processes; FMEA, Risk Assessments, Process Validation, DOE, Gage R&R and GD Failure investigation techniques, statistical quality control, protocol & report preparation and non-conforming product controls; QSR 21 CFR 820, ISO 9001, ISO 13485, IEC 60601 and ISO 14971; Develop protocols including Design Verification, IQ, OQ, PQ, Special Process Validations and Test Method Validations; Providing engineering support for regulatory notifications and submissions; Plastic & Sheet Metal Design & manufacturing Methodology; Plastic & Metal Injection Molding Processes; Finite Element Analysis with ANSYS and Dynamic Mechanism models creation with Creo Software; and 1D and 3D Tolerance stacks with CE Tol Softwar ... (truncated, view full listing at source)