We anticipate the application window for this opening will close on - 10 Jan 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

In this exciting role as a Sr. Process Development Engineer - Extrusion, you will be responsible 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.

At Medtronic, we help 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.

As the Sr. Process Development Engineer - Extrusion, you will:

• Develop new extrusion process to meet delivery catheter system requirements.

• Provide technical and sustaining engineering support in a manufacturing area.

• Recommend and implement equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products.

• Integrate equipment and material capabilities to meet process module target specifications and technology target specifications.

• Review product development requirements for compatibility with processing methods to determine costs and schedules.

• Interact 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.

• Lead 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.

• Develop manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.

• Ensure processes and procedures are compliant with regulations.

Must Have: Minimum Requirements

• Bachelors degree required

• Minimum of 4 years of relevant experience, or advanced degree with 2 years of experience

Nice to Have

• Extrusion Experience

• Preferred hands-on-experience in extrusion process development with 4-7 years of experience

• 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)

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our va