Process Engineering Manager | Medical Injection

About the role

We are seeking a Process Engineering Manager to lead the development, validation, improvement, and transfer of plastic injection molding processes used in medical manufacturing. The role blends hands‑on technical leadership with people leadership, guiding scientific molding practices, process development, and troubleshooting while mentoring engineers responsible for new and existing programs. The manager will collaborate closely with Manufacturing, Quality, Tooling, and New Product Development teams.

Responsibilities

• Lead scientific molding and injection molding process development.
• Conduct IQ/OQ/PQ and overall process validation.
• Manage polymer material selection and handling.
• Drive mold design improvements and optimize processing equipment.
• Support new product launches with robust molding processes.
• Perform root‑cause investigations and implement corrective actions.
• Ensure compliance with ISO 13485 and continuous‑improvement initiatives.
• Mentor and develop engineering staff, fostering technical growth and leadership.
• Coordinate with Manufacturing, Quality, Tooling, and New Product Development to align process objectives.

Requirements

• 7+ years of plastics processing experience with deep injection molding expertise.
• Experience in medical‑device manufacturing and process validation.
• Proven leadership experience, including mentoring technical personnel.
• Ability to manage multiple programs and drive continuous improvement.

Desired Skills

• Scientific molding techniques and best practices.
• IQ/OQ/PQ protocol development and execution.
• Polymer material knowledge and selection.
• Mold design, analysis, and improvement.
• Processing equipment setup, optimization, and troubleshooting.
• Root‑cause analysis and problem‑solving.
• Familiarity with ISO 13485 requirements.
• Strong communication and cross‑functional collaboration skills.