Tech Pack Designer Jobs in Massachusetts (NOW HIRING)

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.

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.