Process Development Extrusion Engineer II.

2 weeks ago

Beverly, United States Medtronic Full time

Careers that Change Lives

In this exciting role as a Process Development Engineer II , you will have responsibility for developing catheter extrusion and other related processes. The Danvers Extrusion center of excellence is one of the largest polymer processing plants in the medical device industry with over 30 active extrusion lines. Medtronic helps patients all over the globe to alleviate pain, restore health, and extend life. This role reports to the product development manager and works independently or with a team of engineer(s) working on next generation heart valve delivery catheter systems.


A Day in the Life

Responsibilities may include the following and other duties may be assigned.

Develops new extrusion process to meet delivery catheter system requirements. Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations. Must Have: Minimum Requirements

Bachelors degree required Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience
Nice to Have
Extrusion Experience Preferred hands-on-experience in extrusion process development with 2-5 years of experience This is a Flexible position, people with lower/higher experience level are welcome to apply to this position and will be well compensated / positioned accordingly. Extrusion experience in developing any one or more of the following process is preferred. Multi-lumen extrusion Vacuum forming extrusion Shrink tubing Intermittent / full A/B extrusion Braided catheter extrusion Extruded Coating Multilayer co-extrusion Bump tubing Experience in process validations, statistics and SPC using Minitab software Familiar with design controls, FDA regulation - ISO 13485, 21 CFR 820, and CGMP practices Good working knowledge of GD&T Generate and conduct validations independently and assist technicians and engineers in executing validation protocols (IQ/PD/PC/OQ/PQ/TMV)

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