We anticipate the application window for this opening will close on - 1 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

We anticipate the application window for this opening will close on - 1 January 2025.

This is an exciting opportunity to join the Manufacturing Engineering team at Plymouth Nathan Lane. In this role as a Senior Manufacturing Engineer, you will have responsibility for developing, characterizing, and validating new & existing process technology. The focus will be on supporting the stent manufacturing value stream. This role will collaborate with the various cross-functional teams inside and outside of the plant including but not limited to Operations Innovation, Quality, Regulatory, R&D, Operations, Technicians, and external vendors/consultants. This is an in-person role with very limited travel required.

This role is at the Plymouth Nathan Lane facility which supports the Peripheral Vascular Health (PVH) Operating Unit (OU). The PVH OU brings our various peripheral vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.

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

• Sustains & improves the day-to-day manufacturing process line(s).

• Drives continuous improvement efforts through A3’s & projects for safety, quality, delivery, & cost.  (i.e.  cost reductions, programmatic savings, automation introduction, and yield improvement)

• Perform process development / process validation in support of key projects.

• Apply first principles thinking to complete robust process characterization (process development).

• Leverages a multi-disciplinary approach to solve problems – Physics, Chemistry, Thermodynamics, & Electronics.

• Ability to understand how to flow requirements from a top-level design down to a manufacturing process specification.

• Create and complete validation documentation and route engineering change orders.

• Ability to remain self-motivated and supports the culture and mission of Medtronic.

• Quickly learn and collaborate on product design to help inform manufacturing changes.

• Make use of appropriate technical skills and tools, such as DOE, SPC, hypothesis testing, capability studies, Gemba walks, and “hands on” analysis, to perform in depth analysis, determine root cause, and identify corrective actions.

• Generate actionable ideas to reduce cost, cycle time and increase yield.

Must Have: Minimum Requirements

• Bachelor's degree with a minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Nice to Have

• Quick Learner, detail oriented, and able to make and deliver on commitments.

• New process and/or technology implementation within highly regulated industries.

• Experience with leading/executing process validation activities (installations qualifications, process characterization, operational and performance qualifications)

• Experience interpreting mechanical drawings

• Experience with DFMEA and PFMEA

• Experience with design of experiment (DOE) and other statistical methods

• Work experience with the following: FDA Quality System Regulations, current Good Manufacturing Practices (cGMP), ISO 13485, ISO 9001 standards or equivalent.

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 specifi