Director of Manufacturing

Director of Manufacturing

Fitchburg, MA 01420

We are seeking an experienced and results-driven Director of Manufacturing to lead our manufacturing operations within an ISO 13485 and FDA-regulated medical device environment. This leadership role is responsible for overseeing all manufacturing functions, including injection molding, machining, plating, assembly, and secondary operations, while ensuring safe, efficient, and compliant production.

The Director of Manufacturing will provide both strategic and hands-on leadership to achieve company objectives related to Safety, Quality, Delivery, Cost, and Employee Development. This individual will drive operational excellence, continuous improvement initiatives, profitability, and customer satisfaction while developing and mentoring high-performing teams throughout the organization.

Key Responsibilities

• Lead, develop, and mentor supervisors, team leads, planners, and manufacturing personnel.
• Establish clear performance expectations and provide coaching, feedback, and career development opportunities.
• Support recruitment, onboarding, training, succession planning, and employee engagement initiatives.
• Ensure appropriate staffing levels to meet production demands and business objectives.
• Foster a culture of accountability, teamwork, safety, and continuous improvement.

• Direct all manufacturing operations, including injection molding, machining, plating, assembly, and secondary processes.
• Ensure production schedules, quality standards, and customer delivery commitments are consistently achieved.
• Collaborate with Engineering, Quality, Maintenance, Planning, and Supply Chain teams to optimize operational performance.
• Monitor and improve key performance indicators (KPIs) related to safety, quality, delivery, productivity, inventory, and profitability.
• Lead capacity planning, resource utilization, and production readiness activities for new product launches and product transfers.

• Champion a safety-first culture throughout the manufacturing organization.
• Ensure compliance with all company safety procedures and regulatory requirements.
• Maintain compliance with ISO 13485, FDA regulations, and established quality management systems.
• Support internal and external audits, regulatory inspections, corrective actions, and continuous compliance initiatives.

• Lead Lean Manufacturing and continuous improvement initiatives across all areas of operations.
• Drive productivity improvements, scrap reduction, waste elimination, and cost-saving programs.
• Utilize Lean tools and methodologies including: 5S, Value Stream Mapping, Root Cause Analysis, Visual Management, Kaizen.
• Analyze operational performance data and implement sustainable process improvements.
• Support ERP system optimization and operational efficiency initiatives.

• Ensure products consistently meet customer, regulatory, and internal quality requirements.
• Partner with Quality and Engineering teams to improve process capability and resolve manufacturing challenges.
• Support customer audits, operational reviews, and business meetings.
• Drive initiatives that enhance quality, delivery performance, and customer satisfaction.

Qualifications

• High School Diploma or GED required.
• Bachelor's degree in Engineering, Manufacturing, Operations Management, Business, or a related field preferred.

• 7+ years of progressive manufacturing leadership experience.
• Proven success leading operations in a regulated manufacturing environment.
• Strong knowledge of ISO 13485, FDA regulations, Lean Manufacturing, and continuous improvement methodologies.
• Experience with ERP/MRP systems, production planning, and operational metrics.
• Experience in medical device manufacturing, injection molding, machining, assembly, or related manufacturing processes strongly preferred.
• Demonstrated ability to lead cross-functional teams and drive measurable operational improvements.

• Strong leadership, coaching, and team development skills.
• Excellent communication, problem-solving, and decision-making abilities.
• Ability to analyze operational, quality, and financial data and translate findings into actionable improvements.
• Strong understanding of manufacturing processes, process controls, and performance metrics.
• Proficiency with Microsoft Office and ERP systems.
• Ability to communicate effectively with employees, customers, suppliers, and executive leadership.

Success will be measured by the ability to achieve and improve:

• Safety performance and incident reduction
• Product quality and defect reduction
• On-time delivery performance
• Productivity and labor efficiency
• Cost reduction and profitability improvements
• Inventory accuracy and management
• Customer satisfaction
• Employee engagement, development, and retention
• Continuous improvement results and operational excellence initiatives

This is an exciting opportunity to make a meaningful impact within a growing medical device manufacturing organization. You will play a key role in shaping operational strategy, developing high-performing teams, and driving world-class manufacturing performance while contributing to products that improve patients' lives.

Competitive salary, comprehensive benefits package, professional development opportunities, and the ability to influence the future growth and success of the organization.