Sr. Development & Implementation Engineer

As a key member of the OEM Engineering team, the Sr. Development & Implementation Engineer will be responsible for leading and managing multi-functional teams in taking customer-designed components from prototype to full production, including: process validation, fixture design and validation, developing standard costs, training production personnel and documentation consistent with the Quality System implementing new methods and capabilities continuation engineering on new and legacy products new product prototype development-will help put prototypes from the R&D labs to the clean room. The successful candidate will also be responsible for training engineers, technicians and production personnel as well as finding and qualifying suppliers of new capabilities in both services and equipment. Relocation is not offered. Education Four-year degree in acceptable technical field required; advanced degree in Mechanical, Biomechanical, Biomedical Engineering, Materials or related subjects. Required Experience At least 3 years experience in medical device design or manufacturing cGMP and medical quality system familiarity, including process validation and documentation Experienced in training assembly workers Knowledge of application of basic statistics for medical manufacturing Fixture and/or machine design and implementation 2+-5 yrs relevent job exp. Preferred Experience In-depth experience with extrusion processes and materials for medical devices Familiarity with design and manufacture of reinforced polymer shafts for medical devices Six Sigma Green or Black Belt in medical manufacturing field