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Sr. Manufacturing Engineer

2 months ago

Billerica, United States Medtronic Full time

Position Description:

Sr. Manufacturing Engineer for Medtronic, Inc., located in Billerica, MA. Responsible for providing engineering guidance and project support for the design, development and optimization of products, processes, tooling, and equipment. Work with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO 14971. Demonstrate understanding of design and manufacturing of electro-mechanical catheters. Navigate the requirements of Good Manufacturing Practices (GMP) and Good Documentation practices (GDP). Updating Process Failure Mode Effect Analysis and Design Failure Mode Effective Analysis (PFMEA and DFMEA) and root cause analysis (RCA). Identifying and driving Value engineering and yield improvement projects. Leverage Lean Six Sigma processes, DOE (Design of Experiments) with statistical analysis and Design for Manufacturing and assembly (DFMA), to ensure product meets quality requirements. Develop protocols for Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Gage R&R and Test Method Validations (TMV). Provide insight and ownership for documentations for Non-conforming Material Report and CAPA (Corrective and Preventative Action). Navigate CAD (Computer-Aided Design) Tools including SolidWorks for equipment and fixture drawings. Coordinate Manufacturing Processes and Line clearance for Standard Operating Procedures. Relocation assistance is not available for this position.

Basic Qualifications:

Requires a Master’s degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and two (2) years of experience as a manufacturing engineer or related occupation; or, Bachelor’s degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and five (5) years of experience as a manufacturing engineer or related occupation. Must possess at least two (2) years of experience with each of the following: development and optimization of products, processes, tooling, and equipment; FDA QSR, 21 CFR Part 820, ISO 13485, and ISO 14971; GMP and GDP; PFMEA, DFMEA, and RCA; DOE and DFMA; execution of IQ/OQ/PQ, Gage R&R, and TMV; Lean Six Sigma, NCMR and CAPA; and CAD Tools. Relocation assistance is not available for this position.

Salary: $127,900 to $146,400 per year

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