Senior Manufacturing Engineer

5 days ago


Billerica, Massachusetts, United States Medtronic Full time
Job Summary

We are seeking a highly skilled Senior Manufacturing Engineer to join our team at Medtronic. As a key member of our engineering team, you will be responsible for providing technical guidance and support for the design, development, and optimization of products, processes, tooling, and equipment.

Key Responsibilities
  • Provide engineering guidance and 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 to ensure compliance.
  • Navigate Good Manufacturing Practices (GMP) and Good Documentation practices (GDP) to ensure quality and regulatory compliance.
  • Update Process Failure Mode Effect Analysis and Design Failure Mode Effective Analysis (PFMEA and DFMEA) and root cause analysis (RCA) to identify and mitigate risks.
  • Identify and drive Value engineering and yield improvement projects to optimize manufacturing processes.
  • 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.
Requirements
  • Master's degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field.
  • 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.
Salary

$127,900 to $146,400 per year



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