Director of Electrical & Systems Engineering

TransMedics, Inc.•Andover, MA

4d•Onsite

About The Position

The Director of Electrical & Systems Engineering will plan, design, and oversee the electrical and biomedical infrastructure of our organization to ensure those designs are implemented effectively while meeting the needs of the business and adhering to industry standards. This role also involves leading and mentoring a team of electrical and biomedical engineers, developing long-range plans, strategies, and driving top-level company objectives. This position is onsite 5 days a week.

Requirements

BS or MS in Electrical Engineering, 10 plus years of electrical design experience for medical devices
3 plus years of managing an engineering team; or equivalent combination of education and experience.
Class II or III Medical device experience under IEC 60601

Nice To Haves

Direct knowledge of regulatory requirements and industry standards in the medical device industry.
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.
Strong project management skills with experience leading complex research projects from concept to completion.
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.
Certified Project Manager (CPM) focused on the skills necessary to manage complex R&D projects effectively
Lithium-Ion battery pack design
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.

Responsibilities

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.