Freudenberg Group

Project Engineer I - Injection Molding

Beverly, MA

Sponsorship not specifiedDetected 25 days ago

GMPMedical DevicesProblem SolvingCritical Thinking

About the role

Support the development, documentation, and validation of manufacturing processes (e.g., extrusion, molding, assembly) in compliance with ISO standards, country-specific and GMP regulations.
Develop and maintain technical documentation such as BOMs, routers, manufacturing procedures, and work instructions.
Provide day-to-day engineering support on manufacturing processes, including troubleshooting issues as they arise.
Analyze test data, perform root cause investigations, and implement corrective actions to resolve quality issues and support CAPA/NCR activities.

Bachelor's degree in Engineering, Chemistry, Biology, or related science/technical field.
0-3 years experience in a regulated industry
Knowledge and exposure to injection molding, extrusion, and assembly, including the materials used such as plastic and silicone.
Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.
Familiarity with product testing and inspection methods to ensure compliance with specifications and standards.
Assist in the design and qualification of tooling, fixtures, and equipment, including generating and executing IQ/OQ/PQ protocols as required.
Basic understanding of engineering terminology and manufacturing processes used in medical device production.
Understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971, Knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States)
Basic understanding of process validation principles and reports, process window/repeatability studies, DOE's, IQ/OQ/PQ, and how to validate manufacturing processes to ensure consistent product quality and necessary safety protocols.
Ability to maintain technical documentation, including work instructions, standard operating procedures (SOPs), and production records.

Collaborate with cross-functional teams and customers to implement engineering initiatives, including standardization, continuous improvement activities, process improvements, and engineering change orders.
Interfaces with customers and suppliers on project matters, mold and fixture design, validation, and product quality issues."

This listing is sourced directly from Freudenberg Group's careers page and normalized into a canonical job model.