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. ResponsibilitiesEstablish 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 youMaster’s or bachelor’s degree in engineering, preferred disciplines would include manufacturing engineering, industrial engineering, mechanical engineering and/or electronics5+ years of progressive experience in medical device projects, including scale up from pilot to full production.

Experience with mechatronics systems is strongly desiredDemonstrated ability to gather requirements, author specifications and test procedures, tracking errors, writing reports and generating documentationSolid understanding of root cause analysis techniques used for failure analysisFamiliarity with risk management measurement and control techniquesWorking knowledge of process validation requirements and statistical techniques in regulated industries, medical devices preferredCustomer Focus – Understanding who the customer is and their needsDemonstrated experience working in multi-functional & multi-cultural environments, with multiple sites around the worldInterpersonal Savvy – Quickly acclimating to people and situationsFluent English, both written and verbal is a must. French competency is desired. Represents the ONWARD CODE (values):

Empowered, Committed, Pragmatic, Innovative, Open, Collaborative, PassionateOccasional travel on a global basis may be required. SupervisionIndividual contributor reporting to the Director Manufacturing.