Engineer II, Process

Getinge•Merrimack, NH

33d•$80,000 - $105,000

About The Position

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

Requirements

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

Nice To Haves

Project management experience is preferred.
Experience in a medical device environment or other regulated industry is preferred.

Responsibilities

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 & equipment.
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.
Work closely with Manufacturing and Manufacturing Engineering to support new processes and equipment that have been recently released 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.