Process Engineer

Job Function Summary:

Work cross functionally between product development and manufacturing engineering to develop & optimize new manufacturing processes and equipment that will be transferred to production for commercial release.

Job Functions:

• Provide input to Product Development on new product designs to address Design for Manufacturing (DFM) and Design for Assembly (DFA) requirements.
• Act as a liaison between Product Development, Manufacturing, and Manufacturing Engineering to assure that project deliverables are communicated and agreed upon.
• Assess process failure risks and institute methods of detection and mitigation.
• Develop & optimize processes required for new products.
• Work with internal design/equipment engineers and/or outside equipment vendors to specify, purchase and develop new manufacturing equipment and tooling.
• Work with validation and quality engineers to develop validation plan for new equipment / processes.
• Maintain compliance to Quality System and regulations for new processes and equipment.
• Complete protocols and reports for Equipment Acceptance Testing (EAT), Installation Qualifications (IQ), and Operational Qualifications (OQ).
• 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.
• Create and implement required documentation including but not limited to; equipment history files, manufacturing procedures, test methods, BOM’s, routings, etc.
• Responsible for change orders (ECO/DCO’s) required to release and/or update controlled items.
• Assist in special projects as needed.
• Contribute 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.).
• Project management experience is preferred.
• Experience in a medical device environment or other regulated industry is preferred.

Minimum Requirements:

• Bachelor’s Degree in Engineering, or equivalent work experience.
• Minimum of 3 years of process engineering, manufacturing engineering, or other related experience.

Getinge Group 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.

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