Process Development Engineer, Senior Staff
About The Position
This role strengthens the manufacturing system architecture that enables predictable, scalable execution. We take pride in being a leader in the medical technology space and are driven by a passion to create products that enable next-generation minimally invasive procedures. This role focuses on manufacturing line design, process flow, capacity modeling, and scalability. The Senior Process Development Engineer – Manufacturing Systems owns end-to-end manufacturing line architecture, performance, and scalability. This role defines how processes flow, scale, and validate across production lines while partnering with Automation Engineering, who own custom equipment design and detailed machine controls.
Requirements
- 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)
- 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)
Nice To Haves
- Minitab experience a plus.
- Green or Black Belt certification a plus.
- Demonstrated ability to lead cross-functional engineering efforts and influence technical direction
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.
- Support PFMEA from a manufacturing system perspective; ensure line readiness for IQ/OQ/PQ.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
