Production Manager

X4 Life Sciences; Massachusetts; On-site; USD 120,000 - 160,000; Full time

Job summary

X4 Life Sciences in Massachusetts seeks an experienced Manufacturing Manager to lead production execution for complex medical systems. You will guide daily operations, drive Lean initiatives, and partner with Engineering, Quality, and Supply Chain to scale manufacturing while upholding safety and quality standards.

The role focuses on building a high-performing team, optimizing processes, and delivering on aggressive production goals in a regulated environment.

Qualifications

• Bachelor’s degree in Engineering, Manufacturing, or related discipline or equivalent experience.
• Experience in regulated manufacturing environments (ISO 13485, FDA 21 CFR Part 820) is required.
• Proven ability to lead and develop production teams in a low-volume, high-complexity setting.

Responsibilities

• Lead daily manufacturing operations, directing production teams and build schedules.
• Ensure assemblies meet quality, timing, and production standards.
• Drive Lean improvements: standard work, 5S, visual management, process optimisation.
• Oversee floor activities: workflow, material movement, tooling and equipment readiness.
• Mentor production leads and technicians; support training and skill development.
• Collaborate with Engineering, Quality, Supply Chain, Planning and Logistics for execution.
• Own performance metrics, capacity planning, build readiness, and reporting.
• Oversee testing, commissioning, troubleshooting, and system validation.
• Lead root cause investigations and permanent corrective actions.
• Support engineering changes, readiness reviews, and documentation updates.
• Maintain compliance with quality systems and support audits (CAPA, nonconformance, DHR).
• Scale production through hiring, coaching, succession planning, and cross-training.

Skills

Leadership

Lean manufacturing

ERP/MRP proficiency

Regulatory compliance

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related discipline

Tools

ERP/MRP systems

Job description

Manufacturing Manager / Production Manager – Medical Device Industry

X4 Life Sciences are working with a fast-growing medical device company that is expanding its manufacturing operations and looking to hire a Manufacturing Manager to lead production execution within a highly complex engineering environment.

This is a key leadership position responsible for ensuring the successful build of complex medical systems, driving operational excellence, improving manufacturing processes, and developing a high-performing production team.

The successful candidate will play a critical role in scaling manufacturing capability while maintaining the highest standards of quality, safety, and delivery performance.

Key Responsibilities:

• Lead daily manufacturing operations, managing production teams, priorities, workload allocation, and execution against build schedules.
• Ensure all assemblies are completed on time, meet quality requirements, and align with established production standards.
• Drive continuous improvement initiatives through Lean manufacturing principles, including standard work, 5S, visual management, and process optimisation.
• Manage production floor activities including workflow, material movement, tooling, equipment readiness, and overall manufacturing efficiency.
• Develop and mentor production leads and technicians, supporting training, skill development, and team growth.
• Partner closely with Engineering, Quality, Supply Chain, Planning, and Logistics teams to ensure smooth production execution.
• Own manufacturing performance metrics, capacity planning, build readiness, and production reporting.
• Oversee factory testing, commissioning activities, troubleshooting, and final system validation.
• Lead root cause investigations and corrective actions for manufacturing issues, driving permanent improvements rather than temporary containment.
• Support engineering changes, manufacturing readiness reviews, work instruction improvements, and process documentation updates.
• Maintain compliance with regulated quality systems and support audit activities, including CAPA, nonconformance management, and device history records.
• Build a scalable production organisation through hiring, coaching, succession planning, and cross-training initiatives.

Requirements:

• 7+ years of manufacturing experience, including 3+ years leading production teams.
• Experience managing manufacturing operations in a low-volume, high-complexity environment such as medical devices, aerospace, defence, semiconductor equipment, or capital equipment.
• Strong understanding of regulated manufacturing environments, including ISO 13485, FDA 21 CFR Part 820, CAPA, nonconformance, and change control processes.
• Experience using ERP/MRP systems to manage production schedules, work orders, capacity planning, and operational reporting.
• Ability to analyse manufacturing data, identify trends, and use metrics to drive operational improvements.
• Experience developing and implementing standard work, manufacturing procedures, and process improvements.
• Strong leadership, communication, and problem-solving skills with the ability to work cross-functionally.
• Bachelor’s degree in Engineering, Manufacturing, Industrial Technology, Business, or a related discipline (or equivalent experience).

Preferred Experience:

• Lean manufacturing experience, including 5S, OEE, visual management, and continuous improvement methodologies.
• Experience scaling a manufacturing organisation through significant production growth.
• Formal problem-solving training such as A3, 8D, or Six Sigma.
• Experience working within SIOP/S&OP or structured programme management environments.
• Background working with complex engineered systems, large assemblies, or specialised equipment.
• Experience with high-complexity technologies such as vacuum systems, RF systems, cryogenics, high-voltage, magnetic field, or radiation-producing equipment.

This is an exciting opportunity to join a growing medical device organisation where manufacturing leadership will directly contribute to scaling production and delivering next-generation healthcare technology.