Head of Manufacturing/Site Lead

Medcura, Inc. is a leading innovator in advanced medical devices, with a specialization in polymeric materials, both natural and synthetic. We are committed to developing life-saving technologies that redefine standards in medical treatment. As we expand, we are seeking a Head of Manufacturing / Site Lead to oversee our headquarters' manufacturing operations and drive excellence in our production capabilities.

Role Summary and Key Responsibilities

The Head of Manufacturing / Site Lead will be responsible for the overall leadership and strategic direction of Medcura's manufacturing operations. This role is pivotal in ensuring efficiency, compliance, and scalability in production processes, with a strong emphasis on polymeric medical devices. The ideal candidate will bring deep expertise in medical device manufacturing, with at least 10 years of experience, and a background in chemical or biomedical engineering.

• Strategic Leadership: Oversee and direct manufacturing operations at Medcura HQ, ensuring alignment with company objectives.

• Production Oversight: Lead end-to-end manufacturing processes for polymeric medical devices, ensuring efficiency, scalability, and regulatory compliance.

• Process Optimization: Implement lean manufacturing principles and continuous improvement initiatives to enhance productivity and cost-effectiveness.
• Quality & Compliance: Ensure all manufacturing activities adhere to FDA, ISO 13485, and GMP regulations.Maintain a high standard of quality assurance.
• Team Management: Build, mentor, and lead a high-performing manufacturing team, fostering a culture of excellence and innovation.
• Cross-functional Collaboration: Partner with R&D, Quality, and Supply Chain teams to drive seamless product development and commercialization.
• Technology & Innovation: Drive advancements in polymeric processing and manufacturing technologies to enhance Medcura's competitive edge.
• Operational Efficiency: Oversee budgeting, capacity planning, and resource allocation to support company growth.
• Site Leadership: Serve as the senior leader for Medcura's HQ manufacturing site, ensuring operational integrity and alignment with corporate strategy.

Requirements

• Education: Bachelor's or Master's degree in Chemical Engineering, Biomedical Engineering, or a related field.

• Experience: Minimum 10 years in medical device manufacturing, with a focus on polymeric medical devices.

• Regulatory Expertise: Strong understanding of FDA, ISO 13485, and GMP compliance.

• Technical Skills: Deep knowledge of polymer processing, medical device production, and manufacturing automation.

• Leadership: Proven track record of leading manufacturing teams and scaling production in a medical device environment.

• Problem-solving: Strong analytical and troubleshooting skills to optimize processes and drive operational excellence.
• Experience in biodegradable or bioresorbable polymers. (preferred)
• Background in process validation, technology transfer, and supply chain integration.(preferred)
• Experience working in both startup and established medical device environments. (preferred)