Director of Electrical Systems & Systems Engineering - Medical Devices - Andover, Mass- $150,000 to $200,000
LOCATION: Andover, Massachusetts
SALARY: $150,000 to $200,000 Our client was founded to address the unmet need for more and better organs for transplantation and has developed the Organ Care System (OCS) technologies to preserve organ quality, assess organ viability prior to transplant, and potentially increase the utilization of donor organs for the treatment of end-stage heart, lung, and liver failure. The company’s National OCS Procurement (NOP) program was developed to maximize the utilization of donor organs in the US.
- As the Director of Electrical & Systems Engineering at our company you will have the unique opportunity to be part of a pioneering team that’s changing organ transplantation technology.
- The Director of Electrical & Systems Engineering will plan, design, and oversee the systems infrastructure of our organization. They ensure that systems are designed and implemented effectively, meeting the needs of the business and adhering to industry standards.
- This role also involves leading and mentoring a team of systems engineers, developing long-range plans, strategies, and driving top-level company objectives.
- Responsible for the electrical architecture, design and testing for the Next Generation Organ Care System while ensuring compliance with project requirements and regulatory standards.
- Provide leadership, oversight and guidance to internal and external design teams for new and legacy products, complaint investigations, and obsolescence.
- Possess a hands-on approach to developing electrical engineering strategies, prototypes and designs for new products and to support existing product lines.
- Establish electrical design requirements and specifications for development efforts.
- Create documentation for electrical designs including formal cross-functional design reviews, theory of operation, DFMEA, and complete release packages consisting of fabrication drawings, assembly drawings, Gerber packages, and their design source files.
- Lead the verification strategy of electrical subsystem designs, including generation of protocols and reports using both internal testing resources and external testing laboratories.
- Develop reliable manufacturing test processes and associated fixtures and process control methods.
- Lead the support of contract manufacturers for supply of PCBAs and components.
- Address field issues by determining root cause and implementing corrective actions as necessary.
- Develop and monitor EE department goals to achieve corporate and project goals.
- Perform team project planning, budgeting and scheduling.
- Complete tasks in a timely manner per plan without direct supervision.
- Collaboration with internal organizations; Quality Assurance, Supply Chain, etc.
- Direct management of Senior and Principal level Electrical, Systems and Biomedical Engineers and including annual performance reviews and identifying opportunities for professional development.
- Oversight of design contractors co-ops and interns as needed.
- Reinforce awareness of the state-of-the art for electrical products, components, design methodology and EDA software.
- Proven ability to effectively manage a team (internal and external) to deliver high quality, robust, complex electromechanical medical devices that comply with US and International safety and EMC requirements (IEC 60601, RTCA DO-160, etc.).
- In-depth knowledge of and experience with medical device development across the entire product development lifecycle from concept to commercialization.
- Class II or III Medical device experience under IEC 60601
- Proven experience designing, testing and formal verification of digital and analog designs, including electrostimulation or ECG monitoring, microprocessor-based electromechanical designs, analog front end data acquisition, motor control, communications interfaces, power supplies, and battery controller designs.
- Experience with Altium design suite and Cadence OrCAD and Allegro PCB Designer are preferred as well.
- Ability to communicate ideas and information clearly, effectively and frequently (oral and written).
- Ability to exercise independent judgment and to act independently to obtain results.
- BS or MS in Electrical Engineering, plus a minimum of ten years of electrical design experience for medical devices and 3 years of managing an engineering team; or equivalent combination of education and experience.
- Direct knowledge of regulatory requirements and industry standards in the medical device industry.
- Strong project management skills with experience leading complex research projects from concept to completion.
- Certified Project Manager (CPM) focused on the skills necessary to manage complex R&D projects effectively
- Lithium-Ion battery pack design
- Full MS WORD Resume
- Required compensation
- Contact information
- Availability
Recruiting Manager
INTERMEDIA GROUP, INC.
EMAIL: [email protected]
LINKEDIN:
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