Direct a team including Mechanical, Hardware, Electrical, Electronics engineers, and their activities to attain business goals consistent with cost, high quality, reliability, and delivery requirements. Coordinate with departments including Supply Chain, R&D, Commercial, Quality and Regulatory to improve existing processes for new and mature products. Leverage global offshore teams, providing technical guidance, mentorship, and professional development opportunities in support of launching electro-mechanical products, through streamlined collaboration and process optimization. Responsible for the development of electronic-mechacia systems and components as well as the design and development of capital medical devices. Navigate the complexities of various government and industry regulatory standards including FDA Quality Systems Requirements (QSR), ISO 13485, ISO 9001, ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, and IEC 60601-2-2. Manage electrical safety and electromagnetic compatibility (EMC) / electrostatic discharge (ESD) testing, implement robust design techniques, to reduce field failures and improve product reliability. Utilize digital and analog hardware design to include custom digital, analog, and power electronics circuit design, off-the shelf equipment with high-voltage and high-current power systems. Navigate Basic input/output system (BIOS), Unified Extensible Firmware Interface (UEFI), Quantum’s Network eXecutive (QNX), and Linux operating systems on single board computers, Field-Programmable Gate Arrays (FPGAs) and embedded processors, improving system boot times and enhancing overall performance. Leverage electronic design, analysis and library tools including Cadence OrCAD, Cadence Allegro, and HyperLynx. Utilize Design for Manufacturing (DFM), Simulation Based Design (SBD), Design for Assembly (DFA), First Product Approval (FPA), Value analysis and Value Engineering (VAVE) methodologies. Utilize Plastic Injection molding and Metal casting, ensuring dimensional accuracy and reducing scrap rates. Responsible for Failure Mode and Effect Analysis (FMEA), and Design Verification Plan and Report (DVP&R) identifying and mitigating high-risk failure modes, resulting in significant reduction in warranty claims.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Job Type
Full-time
Career Level
Manager