What You Will Do

• Lead development, qualification, and optimization of injection molding processes, including tooling input, process characterization, and validation (IQ/OQ/PQ/CSV).
• Manage technical execution of product transfers and manufacturing readiness activities to meet project scope, timeline, cost, and quality targets.
• Partner with external molders, tooling suppliers, and equipment vendors to align on technical requirements and deliver qualified processes on schedule.
• Develop and maintain technical documentation, including URS, FAT/SAT protocols, validation plans/reports, PFMEAs, control plans, and work instructions.
• Apply structured problem-solving methodologies (e.g., DOE, SPC, root cause analysis) to improve process capability and reduce variability.
• Provide design for manufacturability (DFM/DFA) feedback using CAD, including gating, draft angles, material flow, and tolerance strategies.
• Coordinate cross-functional activities with R&D, Manufacturing, Quality, Sourcing, and Facilities to ensure compliance with regulatory and operational standards.
• Support measurement system selection and validation, including MSA and Gage R&R, to ensure data accuracy and process control.

What You Will Need

Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Plastics Engineering, or related field.
• Minimum 4 years of experience in injection molding manufacturing, including tooling, materials, and process validation.
• Minimum 2 years of experience supporting product transfers or new product introduction in a regulated manufacturing environment.
• Experience applying statistical methods such as SPC, DOE, PFMEA, and process capability analysis.
• Experience working with CAD tools (e.g., SolidWorks) for design for manufacturability.
• Proficiency in Microsoft Excel and PowerPoint.

Preferred Qualifications

• Advanced degree in Engineering, Manufacturing, or Engineering Management.
• Experience in regulated industries such as medical devices, pharmaceuticals, or food manufacturing.