Job Responsibilities
- Develop and execute the company's manufacturing and operations strategy in alignment with overall corporate goals.
- Lead long-term capacity planning, technology adoption, and manufacturing excellence initiatives.
- Partner with R&D, Quality, and Commercial teams to ensure smooth technology transfer and product scale-up.
- Represent the manufacturing organization in executive meetings and cross-functional decision-making.
- Ensure effective supply chain management, including vendor qualification, procurement, and inventory control.
- Establish key performance indicators (KPIs) to monitor and optimize operational performance.
- Ensure full compliance with ISO 13485 and other global regulatory requirements.
- Build, mentor, and retain a high-performing operations team.
- Drive a culture of accountability, collaboration, and innovation.
- Champion employee engagement and continuous learning initiatives.
- Develop and manage annual operating budgets for manufacturing and operations.
- Identify cost-saving opportunities without compromising quality or compliance.
- Support due diligence and integration efforts in mergers, acquisitions, and strategic partnerships.
Qualifications and Experience
- Bachelor's degree in Biomedical Engineering, Biotechnology, Manufacturing, Computer Science and Technology or a related field.
- Minimum 12 years of experience in the IVD or medical device industry, with at least 3 years in a senior leadership role.
- Proven experience in managing large-scale, regulated manufacturing operations.
- Deep understanding of ISO 13485, FDA, and IVDR compliance requirements.
- Strong business acumen and experience in strategic planning, budgeting, and resource management.
- Excellent leadership, communication, and stakeholder management skills.
