Senior Process Engineer

Senior Process Engineer

Summary: ATL is seeking a Process Engineer III responsible for meeting production standards, ensuring product quality, and supporting the implementation of new projects. This role involves developing manufacturing processes for medical devices, including molding, extrusion, bonding, curing, electrical testing, and other complex assembly methods. Packaging experience is a plus.

Requirements:

1. Exposure to manufacturing process development and validation activities such as PFMEAs, validation plans, IQ/OQ/PQ, PPAP, scientific molding, design of experiments (DOE), etc.
2. Bachelor's degree in Engineering.
3. Minimum of 5 to 10 years of experience or a combination of education and equivalent experience of 6 years.
4. Preferred experience in designing components for plastic injection molding, metal forming/stamping, and electromechanical devices.
5. SolidWorks certification is preferred.
6. Technical writing skills are preferred.
7. Preferred exposure to manufacturing processes such as injection molding, vertical molding, extrusion, metal forming/stamping, surface-mount technology (SMT), electromechanical devices, etc.

Functions:

1. Ensure compliance with production standards, product quality, and process flow, and support the implementation of new projects.
2. Develop manufacturing processes for medical devices, including molding, extrusion, bonding, curing, electrical testing, and other complex assembly methods. Packaging experience is a plus.
3. Create standard production processes that meet safety, quality, and expected production volume standards for new products.
4. Work directly with external clients to develop their devices within proposed timelines and manage relationships with external suppliers.
5. High levels of critical thinking and problem-solving through root cause analysis methods.
6. Critically think to improve production efficiency. Support CAPA and non-conformities (NCRs) as needed.
7. Conduct risk analysis through pFMEA and establish critical processes.
8. Draft or review product documentation, including manufacturing work instructions, drawings, proposals, and technical reports.
9. Create the master validation plan and execute required validations (IQ, OQ, PQ).
10. Frequently collaborate internally with ATL's engineering, quality, production, and sales groups to ensure the successful launch of new products and line transfer activities.
11. As a senior process engineer, provide guidance and support to junior engineering staff.

About ATL: ATL is a leading company in the medical device manufacturing industry, committed to innovation, quality, and excellence. We offer a dynamic work environment where you can grow professionally and contribute to the development of cutting-edge medical technologies.