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Sr. Process Dev. Engineer

Plymouth, MN 55442

Posted: 02/20/2024 Employment Type: Contract Job Category: Engineering Job Number: 600652 Is job remote?: No Country: United States

Job Description


Additional position detail from the manager below - 
  1. Can you please confirm your top 3 skills sets required?  See job description
  2. What is your target years of experience?  4 plus
  3. When do you plan to start interviewing?  ASAP – most likely later next week (week of 19Feb)
  4. Will you be looking to hire and start ASAP or will the start date be delayed?  ASAP 
  5. Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)?  100% onsite role


Careers that Change Lives

 

In this exciting role as a Senior Manufacturing Engineer on the Plymouth Nathan Lane project engineering team, you will have responsibility for executing a broad range of projects.  Projects supported in this role can span from capacity expansion, equipment end of life replacement, yield improvement, technology change implementation, quality improvement and lean transformation initiatives. This role will collaborate with the various cross-functional teams inside and outside of the plant including but not limited to 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.

 

A Day in the Life

 

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

 
  • Perform process development / process validation in support of the PMO road map.
  • Create and complete validation documentation and route engineering change orders.
  • Ability to remain self-motivated to push through required documentation to support changes.
  • 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.
  • Ability to understand how to flow requirements from a top-level design down to a manufacturing process specification.

 

Must Have: Minimum Requirements

 

Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality

 

Nice to Have
 
  • 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.
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