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:

Role Summary

Senior Manufacturing Manager

process & equipment readiness, supplier/CMO management, compliance, capacity planning, cost/yield improvement, and building a high-performing manufacturing team

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