Senior Manager Manufacturing Operations IVD Products

Primary Healthtech Pvt. Ltd

Sector 10

On-site

INR 3,500,000 - 5,500,000

Full time

6 days ago

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Job summary

Mobilab, part of Primary Healthtech Pvt. Ltd, seeks a Senior Manager Manufacturing Operations to own end-to-end manufacturing of IVD products. You will drive shop-floor discipline, coordinate across procurement, QC, inventory, and R&D, and lead RCA/CAPA for quality and compliance.

The role requires hands-on leadership on the shop floor, and experience with CDSCO/ISO 13485 standards. You will scale production from prototype to volume, focusing on QMS and continuous improvement.

Qualifications

4-7 years of experience in IVD/electro-mechanical/regulated manufacturing.
B.E./B.Tech in Electronics/Electrical/Mechatronics/Biomedical Eng or related field.
Cross-functional manufacturing exposure beyond shop-floor supervision.
Knowledge of CDSCO and ISO 13485 QMS documentation/practices.
Experience with RCA, CAPA, defect resolution, and process improvement.

Responsibilities

Own end-to-end manufacturing operations from material readiness to dispatch.
Drive shop-floor discipline, SOP adherence, and production output.
Lead RCA/CAPA and ensure timely closure and continuous improvement.
Coordinate with procurement, production, QC, inventory, and dispatch.
Oversee equipment calibration, traceability, and QMS compliance.
Use ERP/inventory systems and MS Excel for dashboards and reporting.

Skills

Leadership on shop-floor

RCA & CAPA ownership

Cross-functional coordination

Production planning & execution

Vendor management

Quality & regulatory discipline

Problem-solving

Process improvement

Data-driven reporting

Strong communication

Education

Bachelor's degree in B.E./B.Tech Electronics/Electrical/Mechatronics/Biomedical Engineering

Tools

ERP systems

MS Excel/Google Sheets

Job description

Job Description

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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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

Strong 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