Senior Manufacturing Manager

Job Title

Senior Manufacturing Manager (Medical Devices – Cardiac | Class C & D | Prototype to Market) | Artificial Heart

Location

IIT Madras Research Park: Onsite (No hybrid) | Travel: 20–40% (suppliers, audits, installation/qualification, build support)

CTC: As per experience 

Role Summary

We are looking for a Senior Manufacturing Manager with ~20 years of experience in medical device manufacturing, experience in micro-precision manufacturing (4-5mm size, 5um tolerances), who has taken products from prototype builds through design transfer, pilot production, validation, and commercial scale-up, specifically for high-risk Class C / Class D devices (India classification) and ideally cardiac / critical-care systems.

This role will lead end-to-end manufacturing execution and scale-up: process & equipment readiness, supplier/CMO management, compliance, capacity planning, cost/yield improvement, and building a high-performing manufacturing team. You will be a key partner to R&D, Quality, Regulatory, and Supply Chain to ensure robust, compliant, and scalable production.

Key Responsibilities

1) Manufacturing Strategy & Scale-Up (Prototype → Market)

• Own the manufacturing roadmap from engineering builds (EVT/DVT) to pilot lots to commercial production.
• Define manufacturing strategy: in-house vs CMO, make/buy decisions, process selection, automation roadmap, and line scaling.
• Establish production capacity planning, takt time, staffing plans, and equipment utilization to meet demand.
• Drive design transfer ensuring manufacturing readiness, reproducibility, and documentation completeness.

2) Process Engineering, Industrialization & Design Transfer

• Lead DFM/DFA reviews with R&D and ensure manufacturability, serviceability, and cost targets.
• Create/approve manufacturing deliverables:
• Process flow, routing, work instructions, assembly drawings, tooling specs
• PFMEA, Control Plan, risk mitigations aligned with ISO 14971
• Manufacturing BOM readiness; configuration/version control and traceability
• Develop scalable processes for  electromechanical systems and/or disposables (depending on product mix), such as:
• Precision assembly, torque control, adhesives/potting, sealing, leak testing
• Machining, molding, welding, bonding, coating, cleaning (as applicable)

3) Validation & Compliance (Class C/D Rigor)

• Own manufacturing validation strategy and execution:
• Equipment qualification (IQ/OQ/PQ)
• Process validation and revalidation strategy
• Test method validation
• Calibration & metrology programs; GR&R and measurement capability
• Ensure compliance with applicable standards/regulations (as relevant to markets):
• ISO 13485, GMP requirements, documentation control
• ISO 13485 approach, EU MDR readiness where applicable
• Partner with QA/RA to prepare for and lead audits/inspections (internal, supplier, notified body/regulators).

4) Supplier / CMO Development & Supplier Quality Partnership

• Build and manage strong supplier/CMO relationships for critical components and subassemblies.
• Lead supplier selection, technical evaluation, audits, and quality agreements (with QA).
• Drive supplier process validation, incoming quality controls, and continuous improvement.
• Establish second-source strategies for risk mitigation for critical items.

5) Production Operations & Continuous Improvement

• Own manufacturing KPIs and execution:
• First-pass yield (FPY), scrap/rework, OEE, cycle time, on-time delivery, cost/unit
• Implement lean systems: line balancing, standard work, 5S, kaizen, constraint removal.
• Lead investigations and structured problem solving (8D, DMAIC) in partnership with QA:
• Non-conformances, deviations, CAPA support, containment actions
• Build robust production planning interfaces with supply chain for material availability, inventory health, and lead-time reduction.

6) Manufacturing Documentation & Batch Record Excellence

• Ensure production documentation quality and compliance:
• Device Master Record / Device History Record equivalents (as applicable)
• Batch records, travelers, traceability, labeling control, UDI/readiness if relevant
• Drive digital adoption for traceability (ERP/MES/PLM integration where relevant).

7) Team & Facility Leadership

• Lead, hire, and mentor manufacturing and process engineering teams (operators, technicians, engineers).
• Build competency programs and training matrices for critical operations.
• If applicable: lead facility build-out including layout, utilities, EHS, ESD, controlled environments/cleanrooms, and maintenance systems.

Required Qualifications

• Bachelor’s/Master’s/PhD in Mechanical / Production / Industrial / Manufacturing / Biomedical / Electronics Engineering (or equivalent).
• ~20 years experience in medical device manufacturing with end-to-end lifecycle exposure (prototype → commercial).
• Proven experience with Class C / Class D (high-risk) devices and strong familiarity with compliance expectations.
• Demonstrated hands-on ownership of:
• Design transfer & industrialization
• IQ/OQ/PQ and process validation
• Supplier/CMO scale-up
• Manufacturing documentation and audit readiness
• Strong leadership track record managing multi-disciplinary teams.

Preferred / Strongly Desired (Cardiac Focus)

• Experience in cardiac products such as pumps, circulatory support systems, heart-lung/perfusion systems, catheters, blood-contacting disposables, or ICU/critical-care capital equipment.
• Understanding of hemocompatibility-driven manufacturing considerations (cleanliness, surface finish, coatings, contamination control).
• Familiarity with sterilization & packaging validations (as applicable): EtO, Gamma, E-beam, ISO 11607, ISO 11135/11137.

Core Skills & Competencies

• DFM/DFA, tolerance stack-ups, process capability (Cp/Cpk), SPC, GR&R
• PFMEA/Control Plans; structured problem solving (8D, 5-Why, Ishikawa, DMAIC)
• Strong command of documentation discipline and change control
• Vendor negotiations, cost modeling, and contract manufacturing governance
• Strong cross-functional communication with R&D, QA/RA, Supply Chain, and Leadership
• Tools: ERP/MRP exposure (SAP/Oracle/etc.), PLM and change management systems preferred

What This Role Requires (Working Style)

• High ownership, startup-to-scale mindset (structured but fast)
• Comfortable being both strategic and hands-on on the production floor
• Calm execution under tight timelines; strong judgment on risk and compliance tradeoffs