This Process Engineer will be responsible for supporting a product line launch in the Merrimack NH facility. The product is currently manufactured at a Getinge facility in France. Due to the extreme growth and demand for this product, the Merrimack facility was chosen as a second manufacturing site. Initial focus of this position will be to help establish new ISO7 and ISO5 cleanroom manufacturing areas, work collaboratively with the engineering team in France, procurement of all new manufacturing equipment, process development and process validations. This will be a very high pace, high priority project with the goal for product launch by the end of 2021. Once launched into production, this role will transition into a Sustaining Engineering role to support the manufacturing engineering functions for the new product line.
- Develop/research new manufacturing methods and opportunities to support initial pilot production and agreed upon product launch goals.
- Develop & optimize processes required for new products & equipment.
- Provide direction & mentoring to junior engineers & engineering technicians as needed.
- Work with internal design/equipment engineers and/or outside equipment vendors to specify, purchase and develop new manufacturing equipment and tooling as required to support agreed upon goals for product transfer to Manufacturing.
- Establish initial line layouts, manufacturing specifications, equipment history files, BOM's/Routings, procedures and associated documentation.
- Work with Quality engineers to develop validation plan(s) for new equipment / processes.
- Maintain compliance to Quality System and regulations for new processes and equipment.
- Responsible for equipment acceptance testing (EAT), installation qualification (IQ), process development, and operation qualification (OQ) activities related to the successful transfer of production equipment to manufacturing.
- Collaborate with other disciplines as needed to execute Performance Qualification (PQ) activities.
- Coordinate pilot production / pre-release manufacturing.
- Work closely with Manufacturing and Manufacturing Engineering to release new processes and equipment into production.
- Work closely with Manufacturing and Manufacturing Engineering to support new processes and equipment that have been recently released into production.
- Coordinate initial training of manufacturing personnel.
- Responsible for change orders (ECO/DCO's) required to release and/or update controlled items.
- Responsible for the overall transfer of new products to Manufacturing.
- Assists in special projects as needed.
- Contributes to team effort by accomplishing related duties as requested.
Required Knowledge, Skills and Abilities:
- Experience with developing and optimizing new manufacturing processes.
- Experience with introducing new equipment / processes into production.
- Strong problem solving / troubleshooting skills.
- Experience with process control & statistical analysis techniques.
- Excellent communication skills with the ability to present technical information and prepare written reports.
- Able to work in a cross functional team environment.
- Strong computer skills including MS Office Suite (Word, Excel, etc.).
- Experiance with mentoring & providing direction to junior engineering staff.
Project management experience is preferred.
- Experience in a medical device environment or other regulated industry is preferred.
- Bachelors or Master's Degree in Engineering, or equivalent work experience.
- Minimum of 5 years of process engineering, manufacturing engineering, or other related experience.
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.
We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world's most desired medtech company.
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