Project Engineer, Quality Engineering

Position: Project Engineer I
Responsibilitiesarrow_right

* Support the development, documentation, and validation of manufacturing processes (e.g., extrusion, molding, assembly) in compliance with ISO standards, country-specific and GMP regulations.

* Collaborate with cross-functional teams and customers to implement engineering initiatives, including standardization, continuous improvement activities, process improvements, and engineering change orders.

* Assist in the design and qualification of tooling, fixtures, and equipment, including generating and executing IQ/OQ/PQ protocols as required.

* 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.

* Improve productivity and reduce scrap/reject rates through automation, tool/process improvements, effective training of production personnel and process enhancements.

* Interfaces with customers and suppliers on project matters, mold and fixture design, validation, and product quality issues."

Qualificationsarrow_right

* Bachelor's degree in Engineering, Chemistry, Biology, or related science/technical field.

* 0-3 years experience in a regulated industry

* Basic understanding of engineering terminology and manufacturing processes used in medical device production, such as running equipment, injection molding, extrusion, catheter manufacturing, and assembly, including the materials used.

* Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.

* 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.

* Familiarity with product testing and inspection methods to ensure compliance with specifications and standards.

* Ability to maintain technical documentation, including work instructions, standard operating procedures (SOPs), and production records.