A person with an engineering background who will focus on the development of manufacturing processes both with domestic and international suppliers. Manufacturing process development includes the definition, creation, execution of process validation and on-going verification plans. The person will be actively involved in inspections throughout the supply chain, as well as functional testing. The person will interface and build cooperative working relationships with suppliers, customers, and internal employees, therefore excellent written and verbal skills as required.
· Be responsible for driving the development and documentation of manufacturing processes with suppliers.
· Evaluates manufacturing processes by designing and conducting research/testing; applying knowledge of product design, fabrication, assembly, tooling, and materials; working with suppliers and internal machine shops, and soliciting observations from operators.
· Assures product and process quality by designing testing methods, testing finished- product and process capabilities, establishing standards, and validating and/or verifying inspection and manufacturing processes.
· Be responsible for the re-review of product quality, including but not limited to, manufacturing processes based on our risk management process (production and post-production feedback).
· Investigate both production and post-production feedback issues.
· Develop positive relationships and work closely with functional managers to create, manage, and implement on-going verification plans.
· Act as consultant to the Quality, Manufacturing and Engineering organizations to improve Quality and Manufacturing processes including changes to processes and products, including engineering and supplier changes and product transfers.
· Provide Engineering expertise requiring advanced/specialized skills and a broad range of quality engineering expertise.
· Understand and drive Lean manufacturing internally and with suppliers.
· An Engineeringdegree from an accredited four year university is preferred.
· A minimum of 5years of experience in Quality or Engineering in a manufacturing environment.
· Willingness and ability to travel25%, including international travel.
· Strong communication and problem solving skills using fundamental engineering concepts
· Desire to work in a dynamic, fast-paced, and hands-on manufacturing environment.
· Ability to develop alternative approaches to solve complex problems
· Very strong oral and written communication skills
· Strong Analytical skills Ability to cope with multiple complex situations daily
· Strong adaptation of concepts, theories, and principles to problems
· Strong background in applying statistical quality control tools for process and product controls, such SPC, Gauge R & R, Process Capability, and FMEA
· Prior experience writing technical specifications is preferred
· Background in CAD/CAM software (Creo, Solidworks, Surfcam)
· Knowledge of manufacturing equipment, components and assemblies Background in an ISO13485 work environment, including experience with risk management and CAPA (Corrective and Preventive actions).