· Leading builds to ensure smooth transfer of knowledge to production team and provide training to personnel on new products/ processes as necessary.
· Engaging with cross functional design engineering teams to transition new products into manufacturing
· Supporting development of new products by driving design for manufacturability, including of materials cost, reliability, and serviceability with a particular focus on the electro-mechanical assemblies.
· Measure/inspect electromechanical components for form, fit, and function and disposition nonconforming product.
· Updating/creating manufacturing documentation which conform to Quality System Regulations (QSR’s) and ISO standards.
· Researching, specifying and procure new equipment for existing or new processes/assemblies. Design and construct tooling/fixtures for processes or modify existing production equipment as needed.
· Writing and executing Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validations, Design of Experiment (DOE), Process Failure Mode Effects Analysis (PFMEA) and Continuous Improvement Studies/Evaluations.
· Implementing lean manufacturing techniques.
· Performing robust root cause analysis of production issues, implementing appropriate containment, and drive corrective action.
· Bachelor’s Degree in Mechanical or Electrical Engineering
· 7+ years of manufacturing engineering experience in a regulated industry; medical device experience is helpful
· Experience utilizing SolidWorks for design