Manufacturing Manager

Manufacturing Operations:

• Scale manufacturing in support of commercial readiness, including management of near-term growth and controlled environment scale-up
• Manage day-to-day manufacturing operations including in-house production, supply chain management including managing contract manufacturers, inventory control and distribution.
• Direct procedures and policies to achieve production schedules, product standards, compliance with safety standards and operational and capital costs
• Participate in creating tech transfer plans, validation protocols, work instructions and implementation of novel processes.
• Manage manufacturing area in accordance with and ensure compliance with FDA cGMP, ISO 13485, and other regulatory requirements for medical device manufacturing.
• Implement best practices for production planning and execution, supply chain management and inventory/distribution operations.
• Align, direct, and manage manufacturing and support departments within the site to ensure product capacity and quality requirements are met while meeting manufacturing schedules.
• Directly supervise production operators, technicians, and material planners with direct responsibility for the decisions, actions and performance of the team.
• Oversee supply chain and manage our contract manufacturers and suppliers.
• Oversee equipment maintenance, calibration, and validation to ensure optimal performance and compliance.
• Develop budgetary evaluations on manufacturing costs to be used in early project/product feasibility and throughout the product lifecycle

Continuous Improvement:

• Identify, develop, and implement process improvements to enhance product quality, reduce costs, and improve efficiency.
• Participate and recommend strategy and long-term planning of the facility’s operations (including equipment and technology upgrades) to ensure continued success.

Leadership & Team Development:

• Lead the implementation of all process equipment, including IQ/OQ/PQ activities.
• Mentor and develop junior team members, providing guidance on manufacturing practices, inventory control, distribution, and career growth.
• Foster a collaborative and growth-oriented work environment by encouraging knowledge sharing, continuous learning, and teamwork.
• Lead internal training sessions to spread knowledge across the team.
• Communicate regularly with senior leadership about ongoing operations and project progress.

• Master’s degree in a relevant scientific or engineering discipline;
• Minimum 8 years of medical device manufacturing experience, including strong knowledge of FDA, QSR, MDD and manufacturing principles;
• Minimum 4 years of daily operational/general management experience in a leadership role within the medical device industry;
• Proven leadership and mentoring abilities with experience managing teams of technicians and engineers;
• Experience in process development and/or manufacturing engineering, including development and execution of process validation plans and cleanroom scale-up;
• Thorough knowledge of ERP systems, ISO/GMP requirements, and clean room manufacturing;
• Strong background of using root cause analysis, complex problem-solving techniques, and project management skills;
• Strong oral and written communication skills and interpersonal skills with willingness to be held accountable for deliverables;
• High degree of initiative and self-motivation.