Job Description

Purpose

The Director of Manufacturing is responsible for overseeing all manufacturing staff and all manufacturing activities to ensure continuity of production to support organizational goals.

Responsibilities

• Direct and oversee the manufacture of medical devices – including implantable devices – ensuring production, performance, and quality standards are consistently met in accordance with established procedures and aligned with organizational strategy and goals
• Provide after-hours or on-call support remotely or on-site as needed for production, environmental monitoring alarms, personnel issues, and/or emergency events
• Oversee management of production schedules to support distribution and sales forecasts
• Establish production metrics and provide routine reporting to executive management
• Plan, direct, and coordinate Lean Six Sigma process improvement initiatives
• Organize and maintain department structure and teams for optimal, efficient operations
• Support the development of management structures for operational support departments
• Direct and oversee department training programs for new employee onboarding
• Support executive management with long-term operating goals, expansion efforts, and the implementation of new technology
• Drive department accountability for quality and efficiency
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, ISO 13485 and other regulations (as appropriate), and industry standards
• Review and approve reimbursement requests for operational staff
• Author, revise, and maintain procedures in compliance with FDA, AATB, and other applicable regulations
• Oversee management of equipment qualification plan development
• Review and approve equipment and process validation/verification/qualification protocols, execution data, and summary reports in compliance with FDA, AATB, and other applicable regulations
• Collaborate with Product Development/Management to establish and support project timelines
• Plan, direct, and drive implementation of new production processes in collaboration with Product Development, Quality Assurance, and Regulatory Affairs
• Integrate shared leadership and foster collaboration across multi-disciplinary teams
• File and maintain records in accordance with standard operating procedures
• Support internal and external audits
• Develop and maintain relationships with key stakeholders, including vendors, customers, and employees
• Participate in proposal presentations and face-to-face interactions with clients and customers
• Develop and implement the department budget
• Manage direct reports, including establishing and monitoring objective annual goals, providing feedback, and conducting performance reviews
• Recruit, interview, and select personnel for hire
• Travel domestically up to 15% to attend offsite meetings, conferences, and support business initiatives
• Maintain acceptable attendance and punctuality for scheduled work hours and meetings
• Ensure completion of assigned tasks and responsibilities within defined timeframes
• Flexibility to work outside normal business hours during weekdays or weekends with reasonable advance notice to support operational needs
• Perform other duties as assigned

Skills

• Strong communication skills, with the ability to communicate effectively with stakeholders at all levels
• Excellent interpersonal and negotiation skills
• Strong leadership and management skills, with the ability to inspire and motivate teams
• Excellent analytical and problem-solving skills, with the ability to identify opportunities for improvement and implement solutions Ability to work in a fast-paced environment and manage multiple priorities
• Ability to secure and maintain a favorable background investigation and clearance

Qualifications/Requirements

• Bachelor’s degree in life sciences, finance, operations management, or business, or a related field, from an accredited college or university required
• Master’s degree in life sciences, finance, operations management, or business, from an accredited college or university preferred
• At least 10 years of experience in operational management, quality assurance, finance, or relevant cross functional role required
• At least 5+ years of experience in Medical Device Manufacturing Management preferred
• Experience working in environments compliant with cGMP and MDSAP standards preferred
• Clearance of favorable background investigation required

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