Manufacturing Process Engineer

The Manufacturing Process Engineer is responsible for improving manufacturing activities by providing useful data to the manufacturing department as well as collaborating to process development, continuous improvement, validation and documentation activities. This role involves a great analytical sense and a hands-on approach, with an appetite for precise and accurate work.

Responsibilities

• Establish and analyze manufacturing data from external suppliers and within ONWARD manufacturing department. Format the data to make them useful for further analysis and discussions.
• Develop and execute manufacturing process validation plans and re-validation activities, including IQ, OQ and PQ activities.
• Write, update and validate manufacturing work instructions, procedures, bill of materials, DMR and training material.
• Perform rework assessments.
• In collaboration with operators, manufacturing engineering manager and the engineering department, conduct root cause analysis to identify the source of problems. Propose process, supplier and product improvements.
• Become the first point of contact for ONWARD-developed and -supplied equipment and processes.
• Use statistical methods to analyze production performance and work toward quality and efficiency of all processes.

About you

• Master’s or bachelor’s degree in engineering, preferred disciplines would include manufacturing engineering, industrial engineering, mechanical engineering and/or electronics
• 5+ years of progressive experience in medical device projects, including scale up from pilot to full production. Experience with mechatronics systems is strongly desired
• Demonstrated ability to gather requirements, author specifications and test procedures, tracking errors, writing reports and generating documentation
• Solid understanding of root cause analysis techniques used for failure analysis
• Familiarity with risk management measurement and control techniques
• Working knowledge of process validation requirements and statistical techniques in regulated industries, medical devices preferred
• Customer Focus – Understanding who the customer is and their needs
• Demonstrated experience working in multi-functional & multi-cultural environments, with multiple sites around the world
• Interpersonal Savvy – Quickly acclimating to people and situations
• Fluent English, both written and verbal is a must. French competency is desired.
• Represents the ONWARD CODE (values): Empowered, Committed, Pragmatic, Innovative, Open, Collaborative, Passionate

Occasional travel on a global basis may be required.

Supervision

Individual contributor reporting to the Director Manufacturing.