Product Development Engineer(Medical device)

Support areas of Quality Assurance, Design Controls, Risk Management, Manufacturing Controls, and Statistical Techniques for New Product Development (NPD) programs Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports. Coordinate and execute change control activities to support rapid innovation Support design and development activities (i.e., engineering study, feasibility testing, drawing review, etc.) Participate in escalation tasks and activities, including Project Risk Assessments (PRA) Supports or leads test method development/validation activities for Design Verification testing and manufacturing inspections for NPD programs Collaborate with R D and Manufacturing organizations to facilitate the successful execution of the NPD process and launching of robust products Develop complex experiments and tests (including writing and executing protocols) to create, improve, and validate products and manufacturing processes by analyzing results, making recommendations, and developing reports Develop, update, and maintain technical content of risk management files Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes Assign and oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work Other incidental duties assigned by Leadership