Head of Manufacturing/Site Lead

Job Description

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)

Full-time