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Job description for PROCESS DEVELOPMENT ENGINEERS 

1.0  PURPOSE

To establish the responsibilities and activities of all levels within Process Development Engineering. 

2.0  SCOPE

This job description applies to Engineer I, Engineer II, Senior Engineers, Principal Engineers, and Engineering Fellows within the Process Development Engineering function.

3.0  OUTPUTS & ACTIVITIES

 3.1     Process Development for New Products

• Lead the identification/development/qualification of new processes, fixturing/tooling, and technologies related to new product introductions into manufacturing.
• Lead in the development of test and inspection plans to ensure risk mitigation and quality requirements are met.
• Lead in the development of required documentation for process/test validation and test/inspection instructions.
• Collectively work with Product Development teams to ensure quality requirements and project schedules are met.
• Develop and implement manufacturing processes for new products in preparation of commercial production.
• Determine manufacturing equipment requirements.
• Oversee and assist in developing new or revised production procedures.
• Work with other Product Development engineers to ensure that products are optimally designed for manufacturing.
• Assist in the development of manufacturing TCOGS for new product introductions and provide ROI analysis for capital investments.
• Identify and implement alternative process methods that accelerate product development team’s ability in assessing new product design ideas.
• Develop and manage Process FMEA
• Lead and develop the Process Validation Plan (PVP)
• Train technicians and manufacturing associates on manufacturing processes in conjunction with the operations team through product launch.
• Lead the label registration and printing development
• Responsible to ensure process stations are capable of  repeatable outputs (measured through yield requirements)     

3.2   Support Product Launches through transfer to sustaining manufacturing

• Assist in developing new or revised production processes to meet transfer objectives
• Provide technical support in troubleshooting and resolving tooling & equipment issues.
• Review requested process changes to ongoing manufacturing processes.
• Create original manufacturing procedures.
• Work with engineers, designers, QA and Managers to develop and document manufacturing processes and other relevant procedures.
• Author process qualification documentation such as TMV, IQ, OQ and PQ.
• Create and maintain development records for design history files.
• Develop process flow charts
• Responsible for tool file documentation and calibration prior to product launch
• Perform other duties as assigned.

Ensure process stations meet or exceed the required cycle time to meet initial production forecast (typically 18-24 months out)

3.3  Documentation

• Create original manufacturing procedures.
• Work with engineers, designers, QA and Managers to develop and document manufacturing processes and other relevant procedures.
• Author process qualification documentation such as TMV, IQ, OQ and PQ.
• Create and maintain development records for design history files.
• Develop process flow charts
• Responsible for tool file documentation and calibration prior to product launch
• Perform other duties as assigned.

3.4 Supervisory Responsibility

• Assign work to technicians, less experienced engineers and temporary employees as needed.
• Mentor less-experienced process development engineers and technicians
• Oversee and assist in the selection of outside vendors and consultants as required.
• Provide leadership and direction on project teams as it relates to the process development engineering functions.
• Provide leadership and direction for process and business improvements.

Title	Level of Activity	Level of Supervision
Engineer I	Support	Is a mentoree and a higher level Process Engineer will provide direction and review their work prior to submitting deliverables
Engineer II	Support/Lead	May be a mentoree or a mentor, some activities may be performed without supervision where demonstrated capability is shown.  Supervision may be required for larger more complex deliverables.
Senior Engineer	Lead	Is a mentor, most activities are performed without supervision.  May have direct report(s)
Principal Engineer	Lead/Technical Resource	Is a mentor, all activities are performed without supervision. May have direct report(s)
Engineering Fellow	Technical Resource	Is a mentor, all activities are performed without supervision. May have direct report(s)

Level of Activity

• Support – Provide support of an output or activity to a higher level Process Development Engineer
• Lead – lead an output or activity. Support less experienced Process Development Engineers and technicians.
• Technical Resource – provide guidance to less experienced Engineers.

4.0 REQUIREMENTS

4.1  Job Experience and Education

• BSME (or related disciple) and experience, preferably in the medical device field. Relevant experience in lieu of a degree shall be considered on a case-by-case basis.
• Ability to identify, evaluate and select appropriate process technologies and equipment to manufacture medical devices.
• Ability to quickly create and iterate process concepts.
• Ability to articulate tooling and equipment design requirements.
• Strong technical writing ability.
• Manufacturing process knowledge of various polymer and metal materials; specifically in catheter assembly, laser welding and packaging.
• Knowledge of tooling and process to produce component parts.
• Understanding of various manufacturing and production monitoring techniques.
• Understanding of lean manufacturing.
• Ability to use analytical techniques such as DOE and SPC.
• Specialty knowledge may be required in specific instances

4.2  Physical Demands

• Must perform light lifting up to 25lbs
• Working in a controlled enviroment fully gowned
• Ability to workk extended hours as required (all levels)
• Ability to travel as required
• Ability to work around RF and magnetic fields