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Job Opportunity at
One Source Technical, Inc
Posted on May 4
+1 (440) 248-6911
Commensurate with experience.
The Engineering Manager will join a growing global company involved in the design and manufacturing of advanced miniaturized electronic assemblies used in Class II & III medical devices. Employees enjoy working in an apolitical environment where they get broad exposure to a variety of products and technologies that make a difference in people's lives. The Engineering Manager’s mission is to: provide leadership to the engineering staff for all phases of new microelectronic medical device innovation and development – feasibility, development, industrialization, and release to manufacturing.
Responsible for leading innovation programs for microelectronic medical device product development to include: Overseeing PCB circuit design including all hardware, software and integration as needed. Also, design control documentation following ISO 13485, FDA regulatory and cGMP requirements for medical device design, test methods, through and including DFMEA and PFMEA.
Direct engineers formulating designs, cost estimates, Bill of Material (BOM) development, sourcing materials, and application of professionally accepted engineering techniques.
Lead efforts in identifying differentiated products or solutions that address customer needs.
Hands-on experience with medical device development from user defined requirements through design and development and submission filing.
Serve as liaison between internal cross functional teams and external clients in order to ensure that all targets and requirements are identified and met.
Determine and monitor costs and schedules for medical device/equipment projects, and ensure all are completed on schedule and within budget.
Mentor junior members of the team to continuously build talent
Will need to identify needs, recruit, hire, and develop department staff. Further, evaluate staff performance and develop goals and objectives for team members.
Participate in project definition, defining and monitoring schedules, assist in costing and monitoring budgets.
Bachelors Degree in Electrical Engineering or Bio Medical Engineering degree
Engineering management experience in new medical device development and design, and introduction to Manufacturing.
Knowledge of ISO 13485 and FDA medical device design and be knowledgeable of requirements for device submission to the FDA.
Strong electrical engineering leadership with project management and business acumen.
Excellent written/verbal communication skills.
Keywords: Engineering Manager, BSEE, Electrical Engineering, Bio Medical Engineering, ISO 13485, FDA, Class II & III Medical Devices, DFMEA, PFMEA
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