Principal R&D Engineer

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

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&T; 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 Software.

Salary: $150000 to $195600 per year

#LI-DNI

The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).

Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below: Medtronic benefits and compensation plan