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Engineering Manager

2 months ago

Andover, United States TransMedics Full time
Job Description:

Job Summary:

TransMedics was founded to address the growing need for healthier organs for transplantation. We are focused on transforming the standard of care – increasing organ utilization, improving patient outcomes, and reducing transplant costs.

The Engineering Manager for Perfusion Systems plays a pivotal role in driving process improvements and efficiency in manufacturing operations. We are seeking an experienced and dynamic Engineering Manager to join our team and lead our engineering department. The Engineering Manager will oversee the engineering team, manage the process development, and ensure that all projects meet regulatory standards and company objectives. This individual will be responsible for mentoring engineers, collaborating with cross-functional teams, and implementing best practices in engineering management, with an emphasis on automation.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Lead and manage the engineering team, providing guidance, mentorship, and support.
Oversee the design, development, and testing of equipment for the manufacture of medical devices, ensuring compliance with regulatory standards (e.g., ISO 13485, FDA).
Develop and implement engineering strategies and processes to improve efficiency and product quality, with a focus on automation and process optimization.
Collaborate with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to drive projects from concept to commercialization.
Manage project timelines, budgets, and resources to ensure successful project completion.
Conduct performance reviews, provide constructive feedback, and create development plans for engineering staff.
Identify and mitigate risks associated with engineering projects and processes.
Ensure documentation and technical reports are accurate and comply with regulatory requirements.
Stay current with industry trends, technologies, and best practices to maintain competitive advantage.
Drive initiatives in automation to streamline manufacturing processes and enhance productivity.

Qualifications:

Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related field). Master’s degree preferred.
Minimum of 7 years of experience in engineering roles, with at least 3 years in a leadership or managerial position within the medical device industry.
Strong knowledge of medical device development processes, regulations, and standards (ISO 13485, FDA).
Proven track record of managing and delivering complex engineering projects on time and within budget.
Significant experience in automation technologies and their application in manufacturing processes.
Excellent leadership, communication, and interpersonal skills.
Ability to work collaboratively in a fast-paced, cross-functional team environment.
Strong problem-solving skills and the ability to make data-driven decisions.
Proficient in engineering software and tools (e.g., CAD, FEA, MATLAB).
Strong knowledge of medical device regulations (FDA, ISO 13485, etc.).
Demonstrated leadership and team management skills.
Effective communication and collaboration skills.
Familiarity with lean manufacturing principles and continuous improvement methodologies.
Commitment to maintaining the highest quality and safety standards.

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.