Summary:

The Pr. Process Development Engineer is a core cross-functional member of NPD (New Product Development) teams. Responsibilities include ownership of developing the manufacturing process, leading PFMEA, and manufacturing pilot/qualification builds as well as contributing to product design specifications, DVT, and other development team activities. This is an advanced technical position requiring wide-ranging experience with manufacturing processes and the ability to solve complex and in-depth technical problems.

Responsibilities:

New Product Development (80%)

• Serves as operations liaison on NPD teams (manufacturing, supply chain, supplier component engineering, and manufacturing engineering).
• Contributes cross-functionally to product design to ensure design for manufacturability.
• Leads process characterization and development activities (screening experiments, DOE, process mapping for inputs/outputs, equipment design and selection).
• Leads design of process tooling, fixtures, and equipment. This may involve varying degrees of semi-automation.
• Creates manufacturing documentation (SOP’s and records).
• Leads PFMEA activities and contributes to other aspects of Risk Management.
• Leads job safety risk assessments for new processes and equipment designs.
• Leads manufacturing pilot builds and IQ, OQ, PQ.
• Ensures all manufacturing processes are developed with the operator in-mind (ergonomics, safety), Lean methodologies, waste reduction, one-piece flow, and Cycle Time / TAKT Time considerations in-mind.
• Serve as liaison for projects involving outsourcing / contract manufacturing.

Sustaining Engineering (20%)

• Supports Manufacturing and Sustaining Engineering team members as needed to eliminate waste, improve yields, and improve operator safety.
• Designs and qualifies equipment/fixture that improves/streamlines manufacturing processes.
• Performs investigation and material disposition for Non-Conforming Material Reports (NCMRs).
• Performs root cause investigations and develop Corrective Action and Preventative Action (CAPA) plans.
• Responds to manufacturing emergencies and resolve Production line down(s).
• Leads and coordinates activities of technicians in support of equipment/process development, equipment/process trouble shooting, and custom equipment procurement.
• Contributes to developing partnerships with new suppliers. Performs supplier qualifications for 2nd sourcing of components (may involve component design changes).

Requirements:

• Bachelor’s degree in Engineering: Mechanical, Industrial, Manufacturing and Process disciplines will be considered.
• 8+ years of Process Development experience with process design, development, and deployment on Product Development teams.
• Must have prior experience directly supporting Medical Device Manufacturing (trouble shooting, safety improvements, operator training, process control plans, NCMR disposition, etc.)
• Prior experience preferred with catheter manufacturing and process development: reflow, braid/coil transfer, tipping (glass, RF, laser), laser bonding (balloon, joints), marker band crimping, & lubricious coating.
• Experience using problem solving methodologies (DMAIC, PDCA) with tools (process map, thought map, fish bone, cause/effect, DOE) with a variety of variables to solve and eliminate problems.
• Requires working knowledge in DFM, Lean Six Sigma methodologies, as well as DOE and Statistical Process Control.
• Experience working with semi-automation (mechanical, actuators, stepper motor, HMI, PLC’s) either directly or outsourced.
• Effective verbal and written communication skills.
• Excellent attention to detail, flexible, and adaptable to change.
• Must work well in a cross-functional team, be self-motivated, highly organized, and resourceful in solving manufacturing issues.
• Possess team orientation with critical thinking and problem solving/analytical skills.