Production Manager

X4 Life Sciences

Massachusetts

On-site

USD 120,000 - 180,000

Full time

14 days+

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Job summary

X4 Life Sciences is seeking a Manufacturing Manager to lead production execution for complex medical devices. You will drive daily operations, build schedules, and ensure quality, safety, and on-time delivery while mentoring a growing production team.

In this role you will partner with Engineering, Quality, and Supply Chain to implement continuous improvements, standard work, and CAPA-driven corrective actions, maintaining compliant manufacturing processes in a high-stakes environment.

Qualifications

  • 7+ years of manufacturing experience including 3+ years leading production teams.
  • Experience in low-volume, high-complexity environments such as medical devices or related fields.
  • Strong understanding of regulated manufacturing environments (ISO 13485, FDA 21 CFR Part 820, CAPA, nonconformance, change control).
  • Experience using ERP/MRP systems to manage production schedules, work orders, capacity planning, and reporting.
  • Ability to analyze manufacturing data, identify trends, and drive operational improvements.
  • Experience developing and implementing standard work, procedures, and process improvements.
  • Strong leadership, communication, and cross-functional collaboration skills.

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 production standards.
  • Drive Lean initiatives including standard work, 5S, visual management, and process optimization.
  • Manage production floor activities including workflow, material movement, tooling, and equipment readiness.
  • Develop and mentor production leads and technicians, supporting training and growth.
  • Partner with Engineering, Quality, Supply Chain, Planning, and Logistics to ensure smooth execution.
  • Own manufacturing performance metrics, capacity planning, build readiness, and reporting.
  • Oversee factory testing, commissioning, troubleshooting, and final system validation.
  • Lead root cause investigations and permanent corrective actions for manufacturing issues.
  • Support engineering changes, manufacturing readiness reviews, and process documentation updates.
  • Maintain compliance with regulated quality systems and support audits.
  • Build a scalable production organization through hiring, coaching, succession planning, and cross-training.

Skills

Leadership
Communication
Problem-solving
Data analysis
Cross-functional collaboration
Lean manufacturing
Regulatory understanding

Education

Bachelor’s degree in Engineering/Manufacturing

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.

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