The Role
Lead medical device manufacturing operations through lean and Six Sigma initiatives, improving efficiency, quality, and resource utilization. Manage production teams, schedules, inventory coordination, technology integration, regulatory compliance, QMS, audits, and workplace safety. Collaborate with engineering, quality assurance, procurement, and supply chain teams to meet delivery targets while maintaining FDA, CE, ISO 13485, and CDSCO compliance.
Summary Generated by Built In
ABOUT THE COMPANY:
Remidio is a global pioneer in AI-driven eye care, transforming healthcare with innovative ophthalmic equipment. As India’s first to secure CDSCO approval for adaptive ophthalmic AI and CE marking under EU-MDR, we lead early detection of diseases like diabetic retinopathy, glaucoma, and AMD, with ambitions to address systemic conditions like CVD and CKD. Our FDA-registered devices have screened over 16 million patients across 40+ countries, delivering fast, precise diagnoses. Founded 15 years ago with a vision to democratize preventive care, Remidio combines innovation and empathy to make quality healthcare accessible worldwide.
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.
2. Team Leadership and Development:
- 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.
3. Regulatory Compliance and Quality Management:
- 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.
5. Target Delivery and Supply Chain Management:
- 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.
6.Health, Safety, and Environmental Stewardship:
- 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.
Skills Required
- Bachelor’s degree in Engineering, Manufacturing, or a related field
- Minimum 8 years of experience in medical device manufacturing
- Strong knowledge of ISO 13485, FDA, CE, CDSCO regulations, and quality management
- Proven leadership experience in a managerial role
- Expertise in Six Sigma methodologies and manufacturing process improvement
- Strong analytical and problem-solving skills
- Commitment to continuous improvement
- Medical manufacturing background
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The Company
What We Do
Remidio is an innovative ISO 13485 certified medical device company that seeks to create Healthcare Access by combining the simplicity of product design with cutting edge technology and sustainable business model innovations. Remidio uses principles of Design Thinking and involves key stakeholders during the product development process – clinicians, patients, and health workers, with a view to designing product solutions that are simple to use, clinically relevant, reliable, and scalable. Remidio’s CE marked and FDA 510k registered retinal imaging devices have helped screen and impact more than 7.5 million patients in 15 countries globally, as a result of increased access provided by the ease of use and affordability of Remidio’s patented optics on the smartphone platform.
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