Engineer II, Process - Merrimack, NH

Job Overview

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. 

Job Responsibilities and Essential Duties

• 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.

Minimum Requirements

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

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. 

Quality Requirements

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

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.

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

Salary Range:  $80K - 105K - Depending on Experience

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