Job Title: Operations Manager – Medical Devices
Company: DIGIPATH AI: LifeScanners HealthCare Pvt Ltd
Location: Pune
Role Overview
Join our innovative healthcare company as Operations Manager, where you'll build and lead the complete hardware production lifecycle for key medical devices—from component sourcing and manufacturing setup through quality assurance, compliance, and scalable delivery. This hands-on leadership role reports to the CEO, focusing on creating efficient systems and processes in a fast-paced, growth-oriented environment to transform prototypes into reliable, market-ready products while upholding the highest regulatory standards.
Key Responsibilities:
- Establish and manage end-to-end production workflows, including manufacturing setup (layout, equipment, assembly lines), production planning, scheduling, and scaling to meet demand milestones.
- Develop robust supply chain systems from scratch, handling procurement, vendor sourcing/qualification, contract negotiation, logistics, and disruption mitigation for global components.
- Oversee the full device lifecycle: raw material sourcing, in-process manufacturing, final assembly, packaging/sterilization, inventory management, and on-time delivery.
- Implement regulatory compliance frameworks (ISO 13485, CDSCO), preparing for audits, risk assessments, and ongoing adherence.
- Design and enforce quality control programs, including inspections, testing, traceability, statistical process control, and defect analysis to ensure zero-compromise output.
- Build and lead vendor relationships, performance evaluations, and supplier networks while optimizing costs, lead times, and inventory in a lean startup context.
- Drive operational excellence through KPIs (OEE, yield, cycle times), continuous improvement (Lean/Six Sigma), team hiring/training, and cross-functional alignment with R&D/sales.
- Scale production capacity proactively, adapting processes for growth while maintaining efficiency and compliance in a resource-constrained environment.
Required Qualifications & Skills
- Bachelor of Engineering (B.E.) in Industrial, Mechanical, or related discipline, and an MBA in Operations Management or equivalent.
- 5+ years of experience in manufacturing operations, including at least 2+ years in medical devices or regulated healthcare hardware.
- Proven ability to build production systems and operational processes from the ground up.
- In-depth knowledge of medical device regulations and compliance standards.
- Hands-on experience working in high-compliance and time-sensitive production environments.
- Strong expertise in lean manufacturing, Six Sigma methodologies, process design, and scalable system development.
- Experience in vendor negotiation, supply chain optimization, and inventory control.
- Proficiency in quality management tools and regulatory audit preparation.
- Strong analytical skills for KPI-driven decision-making, performance tracking, and forecasting.
- Leadership ability to build, manage, and motivate teams in dynamic startup environments.
- Excellent problem-solving skills, cross-functional communication, and the ability to execute effectively under pressure.
Preferred Experience:
- 3 to 5 years of experience, preferably with success in scaling startups or medtech companies.
- Experience in global vendor management and achieving ISO/FDA certifications in early-stage companies.
- Proven track record of cost reduction, yield improvement, or supply chain optimization.
Job Type: Full-time
Pay: ₹500,000.00 - ₹800,000.00 per year
Work Location: In person
