Senior Staff Process Development Engineer-Industrial

Key Responsibilities

• Design end-to-end process flows, line layouts, takt models, and WIP strategies.
• Perform capacity analysis, bottleneck identification, and staffing optimization.
• Integrate manual and automated steps into cohesive lines; define high level equipment specifications, placement and line interfaces in partnership with automation partners.
• Risk, Data & Validation Support: Support PFMEA from a manufacturing system perspective; ensure line readiness for IQ/OQ/PQ.
• Cross-Site Deployment: Support Costa Rica transfers, ramp planning, and manufacturing readiness.
• Lead process characterization, DOE studies, and statistical validation activity.
• Generate line-level engineering documentation including work instructions, inspection procedures, protocols, and reports.
• Design and execute process validation protocols (IQ/OQ/PQ) from a line and system readiness perspective.
• Contribute to PFMEAs and risk analyses.
• Provide technical leadership for line development initiatives supporting catheter manufacturing.
• Support transfers to Costa Rica by coordinating installation, debug, validation, and training.
• Mentor junior engineers and provide technical guidance to technicians (without direct managerial responsibility).
• Support standardization of production lines, equipment interfaces, and validation approaches across sites.

Education & Experience

• Bachelor’s degree in Mechanical, Industrial, Manufacturing Engineering, or related field.
• 9–12 years of experience in manufacturing systems, industrial engineering, or process development within regulated environments.
• Demonstrated experience scaling complex, small-scale assembly processes into stable, high-volume production lines.
• Experience defining line architecture, equipment requirements, staffing models, and capacity plans in collaboration with automation and operations teams.
• Proficiency in SolidWorks (models, assemblies, drawings).
• Minitab experience a plus.
• Familiarity with materials used in catheter assemblies.
• Experience in Medical device industry or other highly regulated manufacturing environment.
• Demonstrated experience in process characterization, validation, and control (DOE, IQ/OQ/PQ, SPC).
• Green or Black Belt certification a plus.
• Demonstrated ability to lead cross-functional engineering efforts and influence technical direction.