Senior Electrical Engineering Manager
Our client is a global leader in the Medical Device industry, seeking a Senior Electrical Engineering Manager for their facility in the greater Boston area. The Senior Electrical Engineering Manager will be responsible both new product development and management of released image guided products. The ideal candidate will have image guided experience in the Medical Device industry.
Responsibilities of the Senior Electrical Engineering Manager include:
- Design, development and implementation of Image Guided Products
- Responsible for leading the Electrical Engineering team and working with other engineering groups to develop systems to improve patient outcomes
- The Senior Electrical Engineering Manager will be comfortable working with analog and digital domains in the design of large capital equipment and have comprehensive understanding of analog high-power systems, motion controls and x-ray systems
- Products will be designed with contract manufacturing in mind
- Directs and supervises electrical engineering staff for new product development and released products
• New Product Development
o Responsible for assisting in the development of requirements and the execution of resource allocation, plans, and schedules for the development of a market-released medical product
o Collaborate with medical professionals to help define customer requirements, run clinical testing of prototypes, effectively react to key issues/changes to requirements
o Partners with other functional groups to define the product content/feature set and system requirements
o Manages feasibility studies on technical/marketing proposals and related data for designing new products
o Responsible for ensuring appropriate level of product testing and documentation throughout all phases of development
o Plan, design, review, and oversee the testing of devices according to international electrical emission, immunity, and safety standards (EN-60601-1).
o Lead teams that design and develop electro- mechanical products based on defined requirements
o Implement, maintain, and execute the project plans for new technology programs
o Maintain and complete appropriate documentation for new technology programs.
• Released Product Management
o Supervise the execution of design related CAPAs and supports team members by allocating appropriate resources
o Interface with cross-functional leaders to ensure the proper allocation of electrical engineering resources to address released product issues or concerns
o Support internal and external audits
o Plan, design, review, and oversee the testing of devices according to international electrical emission, immunity, and safety standards
• Bachelor’s Degree in Electrical Engineering and 7+ years of Engineering experience with 5+ years of managerial experience OR Advanced Degree and 5+ years of Engineering and managerial experience
Nice to Have
• Familiar with PCB and schematic layout tools
• Extensive knowledge in SPICE tools for simulation
• System level design expertise with high voltages
• Extensive understanding and proven track record of analog electronics design on a broad range of common electronic components and ICs
• Extensive understanding of electronic design reliability and experienced in effective methodology
• Understanding of digital electronics design on both component and protocol levels; both on-board and in-system
• Ability to simulate and predict system performance and experienced in applications of X-ray technology theories and off-the-shelf components
• Understanding of computer hardware and operating system
• Understanding of quality system regulations and the design control process
• Extensive knowledge of international medical electrical safety standards (EN-60601-1)
• Skilled with business and PCB layout and manufacturing software (Mentor Graphics PADS and DxDesigner preferred)
• Skilled with LabVIEW programming, MATLAB/SIMULINK, HDL languages for CPLD and FPGA
• Skilled in signal integrity and power integrity analysis (HyperLynx preferred)
• Experience and knowledge of robotics systems and motion controllers
• Knowledge and experience leading teams and working with electrical and electronic devices in the medical industry
• Knowledge in electrical and electronic manufacturing processes as they apply to the design process.
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