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