Senior Director Manufacturing Jobs

Job Title: Senior Director of Manufacturing

Industry: Medical Equipment Manufacturing

Location: Greater Boston Area

Key Responsibilities:

1. Manufacturing Strategy: Develop and execute a comprehensive manufacturing strategy aligned with the company's business goals and objectives, including expansion plans and capacity scaling.
2. Manufacturing Operations: Oversee all aspects of manufacturing operations, including production planning, scheduling, and execution, to meet production targets and deliver products on time.
3. Quality Assurance: Ensure adherence to strict quality standards and compliance with regulatory requirements, such as FDA's Quality System Regulation (QSR) and ISO 13485.
4. Process Optimization: Continuously improve manufacturing processes to increase efficiency, reduce costs, and enhance product quality.
5. Cross-functional Collaboration: Collaborate closely with R&D, engineering, supply chain, and quality teams to ensure seamless product development and production processes.
6. Resource Management: Manage manufacturing budgets, allocate resources effectively, and make strategic decisions related to workforce and equipment.
7. Regulatory Compliance: Stay current with industry regulations and standards, ensuring that the organization remains in compliance with all applicable laws and regulations.
8. Talent Development: Build and lead a high-performing manufacturing team, providing coaching and mentoring to team members and fostering a culture of excellence and continuous improvement.
9. Supply Chain Integration: Collaborate with the supply chain team to optimize material planning and procurement processes, ensuring a smooth flow of materials to support manufacturing.
10. Risk Management: Identify and mitigate manufacturing-related risks, ensuring business continuity and patient safety.

Qualifications:

• Bachelor's degree in engineering, operations management, or a related field (Master's degree preferred).
• Strong project management and organizational abilities.
• Deep knowledge of medical device manufacturing regulations (FDA QSR, ISO 13485) and industry standards.
• A minimum of 12 years of experience in manufacturing leadership roles within the medical device industry.
• Exceptional communication and leadership skills.
• Certification in lean manufacturing or Six Sigma is a plus.
• Proven track record of successfully managing manufacturing operations and driving process improvements.
• Excellent problem-solving skills and the ability to make data-driven decisions.