Director of Electrical Systems & Systems Engineering

Position : Director of Electrical Systems & Systems Engineering Location : Andover, MA Duration : Contract Job Description : As our 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.

Before applying for this role, please read the following information about this opportunity found below.

At our company, we are driven by our mission to transform the standard of care for organ transplantation and to expand access to life-saving organs for patients in need.

POSITION SUMMARY 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.

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.

MANAGEMENT RESPONSIBILITIES 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.

PHYSICAL ATTRIBUTES General Office Environment May travel up to 10% domestically MINIMUM QUALIFICATIONS 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.

PREFERRED QUALIFICATIONS Certified Project Manager (CPM) focused on the skills necessary to manage complex R&D projects effectively Lithium-Ion battery pack design Every Organ Wasted is a Life Not Saved.

Our company is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide.

Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant.

To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes.

Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do.

Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health.

Best Regards, T Chandra Sekhar

• Technical Sr.

Recruiter Agile Global Solutions, Inc ....."Empowering Enterprises" 193 Blue Ravine Road, Suite 160, Folsom, CA 95630 Direct