Advanced Manufacturing Engineer II

About the position

The Advanced Manufacturing Engineer II (AME) at Medtronic will play a crucial role in the Operations Extended team, focusing on New Product Development (NPD) for Advanced Surgical Technologies. This position involves assisting in the development, qualification, launch, and commercialization of surgical instruments and devices, while working closely with senior engineers. The AME will contribute to the commercialization strategy, ensuring compliance with best practices and fostering a collaborative environment.

Responsibilities

• Assist in the development, qualification, launch, and commercialization of surgical instruments and devices.
• Develop processes and methods for the fabrication and assembly of medical and surgical devices.
• Participate in Design for Assembly (DFA) / Design for Manufacturing (DFM) activities to verify manufacturability of product designs.
• Actively participate in PFMEA, DFMEA, Process Mapping, and Critical to Quality (CTQ) reviews.
• Develop quote packages and author User Requirements Specifications (URS) for equipment and tooling.
• Interact with suppliers during the quoting process and ensure adherence to URS.
• Oversee manufacture and qualification of assembly equipment and tooling.
• Participate in the development of capital expense requests and project schedules.
• Develop protocols and execute factory acceptance testing (FAT) on purchased tooling, systems, and fixtures.
• Create process documentation including standard work instructions and control plans.
• Create process flows, assembly line layouts, and assembly capacity analysis.
• Develop protocols and execute line validation / qualification activities including IQ, OQ, MSA, and PQ.
• Create testing protocols for product and tooling evaluations and summarize findings in Engineering reports.
• Actively participate in Lean and Medtronic Performance Systems (MPS) initiatives.

Requirements

• Bachelor's degree in engineering required.
• Minimum of 2 years of relevant experience, or advanced degree with 0 years relevant experience.

Nice-to-haves

• Bachelor's degree in Mechanical Engineering, Mechanical Engineering Technology, Manufacturing Engineering, or Manufacturing Engineering Technology preferred.
• Experience working in a manufacturing environment, preferably with assembly equipment and automation.
• Familiarity with DFA and DFM principles.
• Experience troubleshooting production issues and continuous improvement of processes.
• Working knowledge of FMEA.
• Experience with process Validations and Qualifications (IQ / OQ / PQ / MSA's).
• Familiarity with Lean Principles, Toyota production System and/or 6 Sigma Methodology.
• Familiarity with GD&T principles.
• Familiarity with statistical analysis including capability, process control, DOE's, control charts, etc.
• Basic understanding of Industrial Engineering principles including balance tables, process flow diagrams, line layouts, ergonomic designs, etc.
• Experience with CREO / Windchill or other 3D modeling software.

Benefits

• Competitive Salary
• Flexible Benefits Package
• Short-term incentive called the Medtronic Incentive Plan (MIP)