4600 Nathan Lane North Plymouth, MN 55442 US
Careers that Change Lives
In this exciting role as a Manufacturing Project Engineer, you will have responsibility for executing a broad range of projects.A Projects supported in this role can span from Equipment Development/Implementation, Process Validation (IQ/OQ/PQ), Corrective and Preventive Action (CAPA), Scrap Reduction and more. AThis role will collaborate with the various cross-functional teams including but not limited to Quality, Regulatory, R&D, Operations and Technicians.A This positing requires a strong problem-solving track record and the ability to manage complex projects to a successful and on-time completion.A Plymouth Engineering seeks candidates who will meet or exceed our customersa expectations by striving without reserve for the greatest possible reliability and quality in our products, processes, and systems by being accountable, having a voice, and taking action. A PVH
The Peripheral Vascular Health Operating Unit 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.
- Ensures arrangement of machines within plant facilities support the most efficient and productive layout.
- Provide detailed engineering analysis and documentation in product disposition, process changes and Corrective and Preventive Action (CAPA).
- Generate actionable ideas to reduce cost, cycle time and increase yield.
- Partner with manufacturing to develop lean principals to implement solutions for product assembly.
- Leads/owns CAPA (corrective and preventative actions) to resolve production and customer issues.
- Identify process improvement opportunities and provide technical solutions via analysis and hands-on interaction with designated processes.
- Make use of appropriate technical skills and tools, such as DOE, SPC, hypothesis testing, capability studies, Gemba walks, and ahands ona analysis, to perform in depth analysis, determine root cause, and identify corrective actions.
- Utilize project management skills to drive continuous improvement initiatives to optimize yield, quality, cycle time and/or ergonomics.
- Create written documents, test plans and reports that demonstrate technical rationale for associated decisions(s) (e.g. qualifications, risk assessments, and work instructions).
- Ensures processes and procedures are in compliance with regulations.
- Perform process development / process validation in support of the PMO road map.
A Must Have: Minimum Requirements Bacheloras 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
- Demonstrated experience leading/executing process validation activities (installations qualifications, process characterization, operational and performance qualifications).
- Demonstrated experience with Test Method Validation, Measurement System Analysis and/or Gage R&R Studies.
- A Nice to Have
- Experience with project management Experience interpreting mechanical drawings Experience with DFMEA and PFMEA Experience with design of experiment (DOE) and other statistical methods Experience leading Corrective and Preventive Action (CAPA) projects
- Work experience with the following: FDA Quality System Regulations, current Good Manufacturing Practices (cGMP), ISO 13485, ISO 9001 standards or equivalent.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.