About the role
Responsibilities:1. Operational Excellence and Lean Manufacturing:
- Develop and execute manufacturing strategies aligned with lean principles to optimize efficiency and minimize waste.
- Utilize Six Sigma methodologies to drive process improvements, reduce variability, and enhance product quality.
- Champion initiatives to streamline workflows, reduce cycle times, and maximize resource utilization without compromising quality.
- Foster a culture of innovation and continuous improvement among production teams, leveraging advanced technology integration.
- Provide strong leadership, guidance, and mentorship to ensure team cohesion, professional growth, and performance excellence.
- Collaborate cross-functionally with engineering, supply chain, and quality assurance teams to achieve operational goals and deliver exceptional results.
- Ensure manufacturing processes strictly adhere to FDA, CE, and ISO 13485 regulations and standards.
- Implement robust Quality Management Systems (QMS) to uphold the highest standards of product quality and compliance.
- Lead regulatory audits and inspections, driving continuous improvement in quality systems and processes.
4.Technology Integration and Innovation:
- Identify and integrate advanced manufacturing technologies to improve production processes and product quality.
- Drive initiatives for the adoption of best in Industry practices to enhance manufacturing efficiency and real-time data analytics.
- Lead pilot projects for new technologies and processes, ensuring scalability and alignment with strategic objectives.
- Collaborate closely with procurement and supply chain teams to optimize inventory management and ensure timely availability of materials.
- Develop and monitor production schedules to meet target delivery timelines while maintaining high standards of product quality and compliance.
- Uphold rigorous safety standards and environmental regulations within the manufacturing environment.
- Promote a culture of safety, sustainability, and responsibility among team members and stakeholders.
Requirements:
- Bachelor’s degree in Engineering (mechanical/Electrical/Biomedical),Manufacturing, or related Field
- Minimum of 8 years’ experience in medical device manufacturing, with a strong background in ISO 13485, FDA, CE regulations, CDSCO and quality management.
- Proven leadership experience in a managerial role, demonstrating success in driving operational excellence and team performance.
- Expertise in Six Sigma methodologies and their application to improve manufacturing processes and product quality.
- Strong analytical skills, problem-solving abilities, and a commitment to continuous improvement.
- Preferable a medical manufacturing background but not necessary. We are open to candidate with strong manufacturing background.