Manufacturing Engineer Manager jobs in Methuen, MA

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.

This position involves overseeing all aspects of the manufacturing process, managing production schedules, ensuring quality control and compliance to company procedures including ISO13485 standards. Responsibilities include managing and leading a team of manufacturing supervisors, coaching and mentoring the team to ensure performance objectives are met, fostering positive employee relations and building a strong culture of Safety, Quality and Continuous Improvement.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop site manufacturing goals and lead execution of operations in support of site goals.
• Manage performance to plan for critical manufacturing metrics / KPI’s including but not limited to Safety-Quality-Delivery-Inventory-Productivity-Cost.
• Monitor production output and adjust as needed to ensure on-time delivery of modules and accessories.
• Manage and supervise the entire manufacturing team and process, ensuring adherence to established procedures and quality standards.
• Optimize manufacturing efficiency and productivity while minimizing downtime and overtime.
• Continuously monitor the accuracy, completeness, and timeliness of manufacturing process from initial assembly to quality and packaging.
• Collaborate with Supply Chain, Quality, and Manufacturing Engineering to resolve component and subassembly issues and improve efficiency in the receiving, inspection and delivery of materials to manufacturing.
• Establish and enforce quality control standards to ensure products meet and exceed usability expectations.
• Collaborate with the quality team for the prompt resolution and disposition of quality issues. Monitor the effective resolution of NCMRs, process and rework activities.
• Provide guidance and support to team members to help them achieve their goals and objectives. Promote a culture of collaboration, continuous improvement and learning within the manufacturing team.
• Efficiently allocate resources, including manpower, equipment, and materials, to meet production targets. Review and adjust resources to meet short- and long-term production demands.
• Coordinate with procurement teams to ensure timely availability of materials.
• Identify opportunities for process improvements and cost reduction.
• Establish best practices such as lean manufacturing, 5S and standard work across operations.
• Implement Lean Manufacturing, maintain and improve the One-Piece Flow processes.
• Develop and implement production plans to meet demand while optimizing resources.
• Collaborate with product development teams to ensure smooth transition from design to manufacturing.
• Provide input on manufacturability, scalability, and quality.

BACKGROUND AND QUALIFICATIONS:

• Bachelor's degree in engineering, Business management, or a related field (Masters’ preferred).
• Proven experience in a manufacturing management role, preferably in medical device manufacturing.
• Five plus years in manufacturing / operations preferred.
• Strong knowledge of medical device regulations (FDA, ISO 13485, etc.).
• Demonstrated leadership and team management skills.
• Excellent problem-solving and decision-making abilities.
• Effective communication and collaboration skills.
• Familiarity with lean manufacturing principles and continuous improvement methodologies.
• Commitment to maintaining the highest quality and safety standards.

EDUCATION: BA, BS or BSN degree in combination with equivalent medical experience.