We are seeking an experienced Principal Process Engineer to implement and oversee advanced injection molding processes supporting state-of-the-art tooling and medical device manufacturing for a key global customer. This role partners closely with customers and internal engineering, quality, and manufacturing teams to establish robust, validated, and highly controlled molding processes. This is a senior, hands-on role ideal for a process expert who understands scientific/decoupled molding methodologies, thrives in regulated medical device environments, and is comfortable working directly on the manufacturing floor while collaborating internationally.
Key Responsibilities
Implement, control, and optimize advanced injection molding processes for medical device components.
Establish and maintain stable processes using decoupled (scientific) molding methodologies, often aligned with RJG principles.
Lead molding process validation activities, including IQ/OQ/PQ, and support validation documentation in compliance with medical device requirements.
Oversee process execution on advanced injection molding equipment and support mold startups and process troubleshooting.
Diagnose process issues, determine corrective actions, and drive continuous improvement initiatives.
Collaborate with quality, tooling, and manufacturing teams to ensure process capability and compliance.
Serve as a technical partner to a top-tier customer based in Denmark, including periodic international travel.
Provide hands-on support on the shop floor and technical guidance to technicians and engineers.
Required Qualifications
Bachelor’s degree in Engineering or a related technical discipline.
Extensive experience in injection molding process engineering within a medical device manufacturing environment.
Strong understanding of decoupled / scientific molding processes (RJG or equivalent methodologies).
Proven experience in establishing and executing molding process validations.
Ability and willingness to be hands-on in a manufacturing setting.
Strong problem-solving, analytical, and communication skills.
Willingness to travel internationally several times per year.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering
Industries
Medical Equipment Manufacturing
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