Director of Electrical & Systems Engineering

TransMedics, Inc.; Andover (MA); On-site; USD 203,000 - 253,000; Full time

Benefits offered by this job

Bonuses

Equity

Medical plan

Dental plan

Vision plan

401K

PTO

Wellness resources

Pet insurance

Job summary

TransMedics, Inc. in Andover, MA is seeking a Director of Electrical & Systems Engineering to lead the electrical and biomedical infrastructure, ensuring designs meet business needs and industry standards.

The role involves mentoring a team of engineers and driving long-range plans and top-level objectives. You will oversee electrical architecture, testing, documentation, and verification strategies, collaborating with Quality Assurance and Supply Chain to deliver robust, compliant medical

Qualifications

• BS or MS in Electrical Engineering.
• 10+ years electrical design experience for medical devices.
• 3+ years of managing an engineering team.
• IEC 60601 medical device experience.

Responsibilities

• Lead electrical architecture, design and testing for medical devices.
• Provide leadership to internal/external design teams for products and investigations.
• Develop strategies and designs for new products and existing lines.
• Establish electrical design requirements and specifications.
• Create documentation including cross-functional reviews, DFMEA and release packages.
• Lead verification strategy with internal and external testing resources.
• Develop manufacturing test processes and fixtures.
• Support contract manufacturers for PCBAs and components.
• Address field issues with root-cause analysis and corrective actions.
• Collaborate with QA and Supply Chain to meet goals.

Skills

Team management

Electrical design

Regulatory knowledge

Collaborative leadership

Education

BS in Electrical Engineering

MS in Electrical Engineering

Tools

Altium

Cadence OrCAD

Allegro PCB Designer

Job description

Position Summary

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 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.
• Develop electrical engineering strategies, prototypes and designs for new products and 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 design source files.
• Lead the verification strategy of electrical subsystem designs, including generation of protocols and reports using internal testing resources and external testing laboratories.
• Develop reliable manufacturing test processes and associated fixtures and process control methods.
• Lead support of contract manufacturers for supply of PCBAs and components.
• Address field issues by determining root cause and implementing corrective actions.
• 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.
• Collaborate with internal organizations such as Quality Assurance and Supply Chain.

Management Responsibilities

• Direct management of Senior and Principal level Electrical, Systems and Biomedical Engineers, including annual performance reviews and identification of professional development opportunities.
• Oversight of design contractors, co‑ops and interns as needed.
• Reinforce awareness of state‑of‑the‑art electrical products, components, design methodology and EDA software.

Minimum Qualifications

• BS or MS in Electrical Engineering.
• 10+ years of electrical design experience for medical devices.
• 3+ 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.
• Ability to communicate ideas and information clearly, effectively and frequently (oral and written).
• Ability to exercise independent judgment and act independently to obtain results.
• Certified Project Manager (CPM) focused on managing complex R&D projects.
• Lithium‑Ion battery pack design experience.
• Proven ability to 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 and experience with medical device development across the entire product development lifecycle from concept to commercialization.

Benefits

• Expected base salary range: $203,050–$253,350.
• Eligibility for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources).
• 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.