Senior Manager Manufacturing Operations (IVD Products)

Experience: 4-7 Years

Function: Manufacturing Operations

Level: Leadership Team

Employment Type: Full-Time

Location: Mobilab, Noida Sec 6.

About the Role

Mobilab is looking for a Senior Manager Manufacturing Operations to take end-to-end ownership of manufacturing operations across our IVD product portfolio, including Biochemistry Devices, Urine Analyzers, FIA Analyzers, and Reagents.

This is a senior, hands-on leadership role responsible for ensuring production discipline, cross-functional coordination, quality compliance, timely batch completion, and continuous improvement across the manufacturing function.

The role will work closely with Procurement, QC, Inventory, Production, Dispatch, R&D;, and other relevant functions, bringing these teams together as one accountable manufacturing unit.

The ideal candidate should be comfortable working on the shop floor, identifying problems proactively, conducting root-cause analysis, and driving corrective and preventive actions through to closure rather than simply escalating issues.

Key Responsibilities

1. End-to-End Manufacturing Operations

- Own end-to-end coordination of manufacturing activities from material readiness and procurement to production, testing, QC, packaging, and dispatch.
- Ensure timely execution and completion of production batches across all product lines.
- Coordinate closely with Procurement, Production, QC, Inventory, and Dispatch to ensure smooth batch execution.
- Monitor production plans against material availability, manpower, equipment readiness, and inventory status.
- Identify potential bottlenecks and risks proactively and implement corrective actions before they impact production.

1. Shop-Floor Management & Production Discipline

- Drive daily and weekly shop-floor discipline, productivity, SOP adherence, and production output.
- Conduct regular shop-floor reviews and personally monitor:

- Assembly activities

- Testing and calibration

- Yield and rejection rates

- Rework and repair

- Process adherence

- Packaging and final inspection
- Ensure production blockers are identified and addressed on the same day wherever possible.
- Establish and monitor production KPIs, batch-level performance, and completion timelines.

1. RCA, CAPA & Continuous Improvement

- Own the Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) process for:

- Production defects

- Process deviations

- Product quality issues

- Field complaints

- Market/customer complaints
- Ensure issues are investigated systematically and CAPAs are implemented and closed within defined timelines.
- Drive continuous improvement initiatives to reduce rejection, rework, downtime, and production delays.
- Ensure recurring issues are identified and permanently addressed.

1. Vendor & Procurement Coordination

- Work closely with Procurement to ensure timely availability of production-critical materials.
- Support vendor qualification, evaluation, development, and performance monitoring.
- Identify and mitigate single-source, long lead-time, and material availability risks.
- Support local sourcing initiatives and vendor negotiations wherever required.
- Build a reliable vendor ecosystem for electronics, components, sub-assemblies, and reagent-related requirements.

1. Quality, Regulatory &

• Documentation

- Ensure manufacturing activities comply with applicable CDSCO requirements and ISO 13485 Quality Management System (QMS) requirements.
- Ensure proper maintenance and traceability of:

- Batch Manufacturing Records (BMRs)

- SOPs and work instructions

- Batch records





- Production and QC records

- Calibration records

- Traceability documentation
- QMS-related records
- Work closely with QC/QA to ensure quality requirements are integrated into daily manufacturing operations.
- Support internal and external audits and ensure timely closure of observations related to manufacturing.

1. Equipment, Calibration &

• Traceability

- Oversee preventive maintenance and calibration schedules for manufacturing and testing equipment.
- Ensure calibration status and traceability of production equipment, measuring instruments, devices, and relevant test equipment.
- Maintain appropriate calibration and equipment records.

1. Electronics &

• Electro-Mechanical Manufacturing

- Oversee manufacturing activities involving:

- PCBAs
- Electronic sub-assemblies

- Mechanical assemblies

- Final product integration

- Testing and calibration

- Packaging
- Ensure adherence to ESD practices, soldering quality, assembly standards, and rework controls.
- Understand and troubleshoot issues related to power electronics, sensors, motors, heaters, batteries, and other electro-mechanical components.
- Coordinate with R&D;/Engineering for production testing, product improvements, and manufacturing-related technical issues.

1. Team Leadership &

• Capability Building

- Lead, develop, and mentor manufacturing technicians, supervisors, engineers, and relevant functional team members.
- Establish clear responsibilities, performance expectations, and accountability within the manufacturing team.
- Identify skill gaps and drive appropriate training and capability-building initiatives.
- Build a culture of ownership, discipline, problem-solving, and continuous improvement.

1. Production Scale-Up

- Support the transition of products from prototype/pilot builds to stable volume production.
- Establish scalable manufacturing processes, SOPs, testing methods, and quality checkpoints.
- Work closely with R&D;/Engineering during product industrialization and design-for-manufacturing activities.

1. Systems, Data & Reporting

- Use ERP/inventory systems for:

- Batch tracking

- Inventory visibility

- Stock reconciliation

- Material planning

- Production tracking

- Dispatch visibility
- Use CRM/support systems to track field complaints and ensure relevant issues are incorporated into RCA/CAPA processes.

- Use MS Excel/Google Sheets for production dashboards, KPI tracking, batch-level monitoring, and management reporting.
- Leverage appropriate AI-assisted tools for documentation, reporting, RCA support, SOP development, and management dashboards.

A Typical Week

Monday:

Review the production/batch plan across all product lines against procurement, inventory, manpower, equipment, and material readiness.

Identify and address risks before they become production stoppages.

Daily:

Conduct shop-floor reviews covering assembly, testing, calibration, yield, rework, packaging, SOP adherence, and production progress.

As Issues Arise:

Lead RCA for production defects, delays, quality issues, and field complaints. Own the CAPA process through implementation and closure.

Ongoing:

Coordinate directly with Production, QC, Inventory, Procurement, Dispatch,



and R&D; to ensure cross-functional issues are resolved without siloed ownership.

Weekly:

Present manufacturing performance, batch completion status, open CAPAs, material/vendor risks, production bottlenecks, and corrective action status to the leadership team.

Products You'll Own

- Mobilab DUO & PRO Portable diagnostic devices
- Urine Analyzers
- FIA (Fluorescence Immunoassay) Systems
- Biochemistry Devices
- Reagents Biochemistry and related consumables

Required Qualifications & Experience
- 4-7 years of relevant experience in IVD, medical devices, electro-mechanical products, electronics manufacturing, or a closely related regulated manufacturing environment.
- Bachelor's degree in B.E./B.Tech Electronics, Electrical, Mechatronics, Biomedical Engineering, or a related discipline.
- Experience should include cross-functional manufacturing exposure, rather than being limited exclusively to production-floor supervision.
- Strong understanding of electro-mechanical manufacturing and the ability to read and interpret schematics, BOMs, and technical documentation.
- Working knowledge of CDSCO requirements and ISO 13485 QMS documentation and practices.
- Demonstrated experience in RCA, CAPA, defect resolution, and process improvement.
- Hands-on experience with production testing, calibration, yield improvement, and rework reduction.
- Experience working with ERP/inventory management systems.
- Comfortable adopting digital and AI-enabled tools for reporting, documentation, and operational analysis.
- Strong understanding of PCBAs, power electronics, sensors, motors, heaters, batteries, and electro-mechanical assemblies.
- Experience in scaling products from pilot/prototype builds to volume production.
- Knowledge of relevant electronics and reagent vendor ecosystems, preferably within the Delhi-NCR region.

Key Competencies
- Solid ownership and accountability
- Hands-on shop-floor leadership
- Problem-solving and structured RCA
- CAPA management
- Production planning and execution
- Cross-functional coordination
- Vendor management and negotiation
- Quality and regulatory discipline
- Data-driven decision-making
- Team leadership and mentoring
- Process improvement mindset
- Strong communication and reporting skills
- Ability to identify and resolve issues proactively

Ideal Candidate Profile The ideal candidate will have 47 years of experience in a manufacturing environment where ownership of outcomes is expected, not just execution of assigned tasks. You should ideally have experience in IVD, medical devices, electronics, or regulated electro-mechanical products, with a practical understanding of how manufacturing, quality, regulatory compliance, procurement, inventory, and engineering come together on the shop floor.

You should be equally comfortable reviewing a BOM or schematic, investigating a production issue, conducting an RCA, coordinating with a vendor, reviewing inventory readiness, and presenting manufacturing performance to leadership.

We are looking for someone who is proactive, hands-on, technically strong, and execution-focusedsomeone who identifies risks early, takes ownership of problems, and drives them through to resolution.

Success in this Role Will Be Measured By

- On-time batch completion
- Production plan adherence
- Reduction in defects, rejection, and rework
- CAPA/RCA closure within defined timelines
- Improved yield and production efficiency
- Material and vendor risk reduction
- SOP and QMS compliance
- Equipment/calibration compliance
- Improved cross-functional coordination
- Successful transition of products from pilot to volume production
- Development and performance of the manufacturing team

📌 Senior Manager Manufacturing Operations IVD Products (Noida)
🏢 Primary Healthtech
📍 Noida