Principal Process Development Engineer

Description

• Contribute to engineering change control, process documentation, and compliance with regulatory and quality standards.
• Conduct DOE studies, statistical analysis (Cpk/Ppk), and risk assessments to ensure robust and repeatable processes.
• Mentor and train junior engineers and technicians, while maintaining a strong individual contributor focus.
• Design and implement custom tooling and fixtures to improve operator efficiency, ergonomics, and manufacturability.
• Partner with Product Development, Quality, and Operations teams to translate designs into stable manufacturing processes.
• Support manufacturing readiness reviews, gate reviews, and process validation activities (IQ/OQ/PQ/PPQ).
• Drive continuous improvement efforts in yield, quality, and production efficiency.
• Prepare detailed process development plans, defining scope, resources, and timelines for assigned programs.
• Serve as a technical lead on cross-functional project teams, supporting Design Transfer and process validation activities.
• Develop, optimize, and validate manufacturing processes for assemblies, including reflow, bonding, molding, and reinforced shaft fabrication.

Requirements

A leading medical device manufacturer is seeking a Senior Process Development Engineer to advance and refine manufacturing processes. The role centers on post–design-freeze activities-tooling, fixture design, process development, characterization, and validation (IQ/OQ/PQ)-to ensure scalable, high-quality production of precision medical devices. This position requires both technical leadership and hands-on process engineering expertise across multi-functional project teams.

• Occasional lifting of up to 25 lbs.
• Strong understanding of Design for Manufacturability (DFM), design controls, and process validation methodologies.
• Primarily office and cleanroom setting; must be able to sit or stand for extended periods.
• Excellent communication and collaboration skills with cross-functional teams.
• Bachelor’s degree in Engineering or related technical discipline (advanced degree preferred).
• Ability to manage multiple complex projects simultaneously in a fast-paced environment.
• Proficiency in SolidWorks, Mastercam, and statistical analysis tools (e.g., Minitab).
• Minimum 7+ years of experience in process or manufacturing engineering within the medical device industry.
• Proven ability to develop and validate new manufacturing processes (IQ/OQ/PQ) in compliance with medical device quality systems.
• Requires use of cleanroom attire and PPE as appropriate.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance