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Our Client seeks a highly accomplished Production Director to ensure the continuous and efficient supply of our innovative medical devices, adhering to stringent specifications and dynamic sales forecasts. This strategic role demands a master-level understanding of supply chain management, production optimization, and quality assurance within a regulated medical device environment. The Production Manager will serve as the pivotal link between our Client and its external production ecosystem, encompassing suppliers, subcontractors, and analytical service providers. This position necessitates seamless cross-functional collaboration with Sales, Marketing, Quality, Regulatory, R&D, and Finance departments, driving operational excellence and mitigating supply chain vulnerabilities.

The incumbent will report directly to the Chief Technology Officer (CTO).

Responsibilities:

Strategic Supply Chain Management:

• Develop and execute comprehensive production planning and scheduling strategies to maintain uninterrupted product availability, including the establishment and management of strategic safety stock levels.
• Proactively identify and mitigate potential supply chain disruptions through advanced forecasting, risk assessment, and collaborative problem-solving with subcontractors.
• Cultivate and manage robust relationships with international suppliers, production subcontractors, and analytical service providers, ensuring adherence to contractual obligations and quality standards.
• Negotiate and manage supplier contracts, optimizing for cost-effectiveness, quality, and delivery performance.

Production Optimization and Quality Assurance:

• Lead the implementation and execution of continuous improvement initiatives to enhance production efficiency, reduce costs, and elevate product quality.
• Oversee the design transfer process for New Product Development, ensuring seamless integration of new products into existing manufacturing workflows.
• Drive the identification, investigation, and resolution of product and production process non-conformities, implementing corrective and preventive actions (CAPA) as necessary.
• Establish and maintain comprehensive production Standard Operating Procedures (SOPs) and records within the Company’s Quality Management System (QMS), ensuring compliance with regulatory requirements.

Operational Excellence and Data Management:

• Implement effective ordering, purchasing, and logistics strategies to support product manufacturing and distribution.
• Ensure the availability of accurate and timely production, analytical, and logistics data for effective stock management and demand forecasting.
• Support production scaling and automation initiatives, collaborating with internal teams and external consultants.
• Manage Facilities management and contracts as required.
• Ensure business continuity through the creation, maintenance and implementation of appropriate plans.

Key Objectives:

• Achieve zero stock-outs and eliminate supply interruptions.
• Maintain a minimum safety stock level of 6 months’ forecasted demand.
• Develop and implement a robust scalability strategy for the Catalyst product line.
• Develop, test, and implement a comprehensive business continuity plan for the Company’s product supply.
• Minimize major non-conformities within the Company’s QMS and supplier QMS.
• Optimize downstream supplier capacity scheduling.
• Achieve measurable year-on-year manufacturing cost reductions on a per-product basis.
• Drive continuous improvement in quality metrics on a functional basis.

Requirements:

• Master’s degree in a relevant technical discipline (e.g., Engineering, Chemistry, Materials Science).
• Minimum of 8+ years of progressive experience in medical device production management, demonstrating a proven track record of success.
• Demonstrated expertise in managing complex supply chains and international supplier relationships.
• Strong understanding of medical device regulatory requirements (e.g., ISO 13485, FDA regulations).
• Proven ability to manage competing priorities within a dynamic and regulated environment.
• Preferred Experience with inorganic chemistry-based products or production processes is highly desirable.

This job description is not exhaustive and may have been condensed for online or mobile viewing. It does not encompass all duties, responsibilities, or aspects of the job, and is subject to amendments at the sole discretion of the Employer. Employees may also perform other related duties as negotiated to meet the organization’s ongoing needs.

Legacy MedSearch has been consecutively featured on Forbes’ list of Best Recruiting Firms in America for 5 years running (2019–2024).