Director of Electrical & Systems Engineering at TransMedics, Inc.

Andover, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

23 May, 26

Salary

253350.0

Posted On

22 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Electrical Architecture, Systems Engineering, Biomedical Infrastructure, Design and Testing, Regulatory Standards Compliance, Team Leadership, Prototyping, Design Requirements Specification, Verification Strategy, Manufacturing Test Processes, Root Cause Analysis, Project Planning, Budgeting, Scheduling, IEC 60601 Compliance, Electrostimulation

Industry

Medical Equipment Manufacturing

Description

Job Description: POSITION SUMMARY 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. 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 Ability to lift up to 25 lbs. May travel up to 10% domestically MINIMUM QUALIFICATIONS 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 PREFERRED QUALIFICATIONS 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. As part of our long-term growth plans, TransMedics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients. Specific timing and role impact may vary. Every Organ Wasted is a Life Not Saved. TransMedics, Inc. 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. Maximize your potential at TransMedics, Inc. www.TransMedics.com TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $203,050-$253,350, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history. Employee Benefit: Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA Dental Vision Healthcare Flexible Spending Account Dependent Care Flexible Spending Account Short Term Disability Long Term Disability 401K Plan Pet insurance Employee Stock Purchase Plan TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS™, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect™ app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS™, TMDX launched its National OCS™ Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. – aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.

Responsibilities

The Director will plan, design, and oversee the electrical and biomedical infrastructure, ensuring effective implementation while meeting business needs and industry standards. This includes leading engineering teams, developing long-range plans, and driving top-level company objectives related to the Next Generation Organ Care System.