Sr. R&D Engineer-New Product Design

Position Description:

Sr. Research & Development Engineer for Covidien LP (a Medtronic company) located in Woburn, MA. Provide engineering support for new Product Design and development including existing product modifications and process design, development and optimization and performance evaluation. Coordinate projects/stages/processes within Product Development. Contributes towards planning and completion of deliverables through building relationships and consensus. Define requirements and system architecture for new product development for electromechanical medical devices. Responsible for the design of components, sub-assembly products using Solidworks. Develop and test prototypes from design specifications, defines processes to properly make and assemble the product and optimizes process. 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), a 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.

Basic Qualifications:

Requires a Master’s degree in Bioengineering, Biomedical, Mechanical Engineering or related engineering field and 2 years’ experience as an R&D engineer or related occupation in R&D engineering. Must possess a minimum of 2 years with each of the following: define requirements and system architecture for electromechanical medical device; design, development and testing of electromechanical medical devices and provide engineering support for product development; 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; and providing engineering support for regulatory notifications and submissions.

Relocation assistance is not available for this position.

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