Engineer I, Process

Job Overview

Assist with the development & optimization of new manufacturing processes and equipment that will be or has been transferred to production for commercial release. 

Job Responsibilities and Essential Duties

• Work with other engineers to 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.
• Assist with production line layouts and installation of new equipment.
• Assist with protocols and reports for Equipment Acceptance Testing (EAT), Installation Qualifications (IQ), and Operational Qualifications (OQ). 
• Execute protocols to complete Equipment Acceptance Testing (EAT), Installation Qualifications (IQ), and Operational Qualifications (OQ). 
• Assist with conducting Performance Qualification (PQ) activities.
• Assist / 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.
• Assist with training efforts on new equipment and processes. 
• Assist with creating 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.
• Maintain compliance to Quality System and regulations for new processes and equipment.
• Assist in special projects as needed. 
• Contribute to team effort by accomplishing related duties as requested.

Minimum Requirements

• High school Diploma with a minimum 3 years’ experience in manufacturing / process engineering.
• Or; Associates Degree in Engineering with 1 year experience in manufacturing / process engineering.
• Or; Bachelor’s Degree in Engineering.

Required Knowledge, Skills and Abilities

• Problem solving / troubleshooting skills.
• Excellent communication skills with the ability to prepare written reports.
• Able to work in a cross functional team environment.
• Computer skills including MS Office Suite (Word, Excel, etc.).
• Experience with developing and optimizing new manufacturing processes preferred.
• Experience with introducing new equipment / processes into production preferred.
• Experience with process control & statistical analysis techniques preferred.
• Experience in a medical device environment or other regulated industry is preferred. 

Supervision/Management Of Others:

N/A

Internal and External Contacts/Relationships

N/A

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Duties are performed in an office environment.

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

75K – 95K with 8% STIP

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