Senior Mechanical Design Engineer
Marlborough, Ma, Us
* Extensive cross-functional and cross-site experience within the company by designing in-house and then collaborating with international sister-site manufacturing facilities. * Designed and developed IPG (implantable pulse generators) for Spinal Cord Stimulation (SDS) and Deep Brain Stimulation (DBS) applications from definition of material specifications and design drawings to the development of product specifications, completion of design verification testing, and drafting of regulatory submission documents. * R&D author of risk management documentation (HA, DFMEA) and design control package to ensure device integrity, patient safety, and adherence to internal quality systems, regulatory requirements, and applicable industry standards.* Mechanical engineering subject matter expert (SME) for IPG design and the testing of MRI compatible implantable devices and components, presenting results to all levels of the organization for phase approvals.* Extensive 3D-modelling experience for medical device and fixturing design (Solidworks).* Perform analysis of results using statistical techniques and software such as Minitab and Matlab.* Presented at internal international technical forums and technical meetings.* Perform and coordinate testing internally or at external test houses to ensure finished devices meet required specifications (e.g., tolerance analysis, fatigue, bend, tensile, crush, drop, water exposure, hermeticity, RGA, current isolation).