Process Engineer, Advanced Manufacturing Engineering

This role will be based out of the Ambu America's Center of Excellence located at the Noblesville, Indiana manufacturing facility. The role has responsibility for Advanced Manufacturing Engineering functions of both the Noblesville, IN and the Juarez, MX manufacturing sites. The expected travel for this role is up to 50%.

Objective:

Responsible for engineering related support of manufacturing equipment and processes used to produce plastic medical components. Activities include process, equipment and tooling validations, continuous improvement, scrap reduction, and capacity improvements or optimization.

Responsibilities and Essential Functions:

• Support and/or Lead project teams to increase productivity, reduce scrap, implement lean manufacturing, improve system availability, safety, and product quality.
• The ability to recognize opportunities and appropriately prioritize projects based on potential improvement and risk is imperative.
• Develop molding and extrusion processes using scientific molding best practices and industry established methods.
• Write, Review, and Execute PVP, IQ, OQ, and PQ documents and summaries. Familiarity with cGMPs, ISO, and other Medical Device Industry regulations and specifications required.
• Perform root cause investigations for the NCR or CAPA processes. Report findings to cross functional team, propose and implement corrective actions and verify corrective action effectiveness.
• Develop SOPs for equipment operation, part inspection, equipment change over, and preventive maintenance activities that are current and accurate.
• Write Capital Appropriations for new equipment required to support Manufacturing. Create justification for approval of investments. Work with vendors to provide quotes and identify system specifications. Coordinate project timelines to meet manufacturing and project requirements.
• Support manufacturing by diagnosing system or process failures and working with Maintenance and/or the Tool Room personnel to implement system fixes.
• Coordinate engineering expertise to identify and implement safety improvements consistent with OSHA standards.
• Collaborate with manufacturing to study, evaluate and improve equipment and processes utilizing data driven analysis, DOE and any other applicable methods.
• All responsibilities and functions listed above are applicable to Ambu manufacturing in Noblesville, IN, USA and in Juarez, Mexico.
• Travel between both sites is required. Onsite work in Noblesville will be approximately 75% and on site in Juarez will be 25%.

Qualifications:

• Bachelors' degree in plastic process engineering or related field.
• 3-5 years of relevant work experience.
• Experience working in the medical device field preferred.
• Must be able to speak, read, write and understand English, Spanish bi-lingual preferred
• Education, training and experience with plastics required.
• Experience with equipment and processes used to manufacture, assemble, test and package plastic components.
• Experience using industry standard methods for developing injection molding processes and corrugate extrusion processes.

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.