1. About the Role

The Head of Process Engineering will provide strategic, technical and operational leadership for the Process Engineering function, with overall responsibility for manufacturing process development, industrialisation, New Product Introduction (NPI), process and equipment qualification, automation, manufacturing technology, continuous improvement and engineering excellence. The role will lead the development and implementation of robust, scalable and cost-effective manufacturing processes for complex medical equipment and ensuring effective industrialization from concept and prototype through production ramp-up, serial production and sustaining engineering.

The position will establish the Process Engineering technology roadmap and drive manufacturing excellence through Lean Manufacturing, Six Sigma, automation, IoT and data-driven process optimization.

The Head of Process Engineering will work closely with Manufacturing, Quality, Supply Chain, Operations teams to ensure manufacturability, production readiness, process capability, quality, productivity, cost competitiveness and long-term manufacturing sustainability.

The role is accountable not only for individual engineering projects, but for the overall performance, capability and strategic direction of the Process Engineering function.

2. Key Responsibilities

2.1 Process Engineering Strategy & Functional Leadership

. Define and implement the Process Engineering strategy, roadmap and annual operating plan in alignment with business and manufacturing objectives.

· Lead the overall Process Engineering function covering process development, industrialisation, NPI, automation, equipment engineering, process validation and continuous improvement.

· Establish engineering standards, methodologies, processes, governance and best practices across manufacturing operations.

· Translate business objectives into measurable engineering priorities, projects and technology roadmaps.

· Establish and monitor functional KPIs covering FPY, OEE, process capability, productivity, cycle time, capacity, DPU, scrap, rework, cost reduction, equipment uptime and NPI readiness.

· Prioritise engineering resources based on business impact, customer requirements, technical risk, capacity constraints and manufacturing priorities.

· Establish a structured engineering improvement pipeline and ensure timely execution of high-impact initiatives.

2.2 New Product Introduction & Industrialisation

· Own the Process Engineering contribution to NPI from product concept through prototype, pilot production, validation, production ramp-up and serial production.

· Establish manufacturing readiness criteria and phase-gate governance for new products.

· Lead cross-functional industrialization activities with Quality, Supply Chain and Operations.

· Drive Design for Manufacturing (DFM), Design for Assembly (DFA) and Design for Testability (DFT).

· Ensure manufacturing processes, equipment, tooling, fixtures, gauges, work instructions and process controls are available before production release.

· Lead manufacturing transfer activities between sites, products and production lines.

· Establish robust production ramp-up and handover processes from engineering to operations.

· Ensure lessons learned from NPI and previous programs are incorporated into future product introductions.

2.3 Manufacturing Process Development & Optimisation

· Lead development and optimisation of manufacturing processes for complex products.

· Establish robust process flows, process parameters, standard operating procedures, work instructions and process controls.

· Drive process capability improvement using SPC, Cp/Cpk, DOE, MSA, capability studies and statistical analysis.

· Identify and eliminate process variation, bottlenecks, waste, defects and non-value-added activities.

· Lead line balancing, cycle-time reduction, capacity improvement and manpower optimisation.

· Establish scalable processes capable of supporting production growth and future product variants.

· Drive standardisation and replication of proven manufacturing solutions across products and production lines.

2.4 Automation, Equipment & Manufacturing Technology

· Define the long-term automation and manufacturing technology roadmap.

· Identify and evaluate opportunities for automation, robotics, machine vision, special-purpose machines, automated inspection and automated testing.

· Lead development, selection, procurement,



integration and commissioning of manufacturing equipment and SPMs.

· Establish technical specifications and acceptance criteria for new equipment.

· Manage external machine builders, automation suppliers and technology partners.

· Ensure appropriate equipment qualification and production acceptance processes.

· Drive migration from legacy equipment and test systems to contemporary, connected and automated platforms.

· Evaluate emerging manufacturing technologies and establish business cases for their adoption.

2.5 Process Qualification & Validation

· Establish and govern the process qualification and validation strategy.

· Ensure appropriate qualification of manufacturing processes, equipment, tooling, fixtures and automated test systems.

· Provide engineering leadership for DQ, IQ, OQ and PQ, where applicable.

· Ensure critical process parameters and critical quality characteristics are identified and controlled.

· Lead process capability studies and validation activities.

· Ensure engineering changes are appropriately assessed, validated and implemented.

· Maintain engineering evidence supporting regulatory and QMS requirements.

2.6 Quality, Reliability & Process Risk Management

· Partner with Quality to establish prevention-oriented manufacturing processes.

· Lead engineering activities related to internal defects, customer complaints, process escapes and manufacturing quality issues.

· Ensure effective use of PFMEA, Control Plans, process risk assessments, 8D, RCA, FMEA, SPC and structured problem-solving.

· Drive reduction of DPU, scrap, rework, customer complaints and manufacturing escapes.

· Ensure corrective actions are technically robust and sustained.

· Identify high-risk processes and establish appropriate mitigation and monitoring strategies.

· Support product reliability and manufacturing robustness initiatives.

2.7 Operational Excellence & Continuous Improvement

· Establish a structured Operational Excellence / Manufacturing Excellence program within Process Engineering.

· Drive Lean, Six Sigma, Kaizen, TPM and structured problem-solving initiatives.

· Lead major productivity, capacity, cost reduction and quality improvement projects.

· Improve OEE, FPY, throughput, cycle time, yield and equipment utilisation.

· Establish a pipeline of engineering projects linked directly to business objectives.

· Ensure improvements are standardised and sustained through appropriate process controls.

2.8 Digital Manufacturing

· Define and implement the Process Engineering digital manufacturing roadmap.

· Drive implementation of IoT, connected equipment, real-time monitoring and manufacturing analytics.

· Establish data-driven monitoring of process and equipment performance.

· Utilise Power BI and similar analytics platforms for engineering and manufacturing performance management.

· Identify opportunities in predictive maintenance, process optimisation, automated inspection, defect prediction, equipment health monitoring and manufacturing analytics.

· Develop strategies to move manufacturing from reactive problem solving toward predictive and preventive engineering.

2.9 Equipment Reliability & Predictive Maintenance

· Establish engineering standards for equipment reliability and maintainability.

· Work with Maintenance and Operations to analyse equipment failure trends.

· Identify critical equipment and establish reliability improvement plans.

· Utilise equipment data, sensors and condition monitoring to identify potential failures.

· Support development of predictive maintenance systems.

· Drive reduction in equipment downtime and unplanned production interruptions.

2.10 Engineering Change Management

· Own the Process Engineering governance for manufacturing engineering changes.

· Review and approve engineering change requirements from a manufacturing perspective.

· Assess impact on process capability, capacity, tooling, equipment, validation, quality and cost.

· Ensure effective implementation of approved changes on the shop floor.

· Ensure all engineering documentation, work instructions, process specifications and validation records are updated.





2.11 Engineering Project & Capital Management

· Lead major manufacturing engineering and industrialisation projects from concept through implementation.

· Develop project scope, schedules, resources, risks and budgets.

· Establish capital expenditure requirements for equipment, automation and manufacturing technology.

· Prepare technical and business cases for major engineering investments.

· Monitor project delivery against cost, quality, scope and schedule.

· Ensure engineering projects deliver measurable business benefits.

2.12 Team Leadership & Organisation Development

· Lead, mentor and develop a high-performing Process Engineering organisation.

· Define organisation structure, roles, responsibilities and competency requirements.

· Recruit, develop and retain engineering talent.

· Establish competency matrices and individual development plans.

· Develop technical specialists and future engineering leaders.

· Establish structured knowledge-sharing and engineering best-practice forums.

· Provide coaching and mentoring in process engineering, automation, problem solving, project management and manufacturing excellence.

· Establish clear performance objectives and KPIs for engineering personnel.

· Build a culture of technical ownership, accountability, innovation and shop-floor engagement.

2.13 Cross-functional & Global Stakeholder Management

· Serve as the principal Process Engineering interface with Operations, Manufacturing, R&D;, Product Engineering, Quality, Supply Chain, Procurement, Regulatory, Maintenance, Global Engineering and Advanced Manufacturing Engineering.

· Represent Process Engineering in senior management reviews.

· Lead technical discussions with customers and strategic suppliers where required.

· Establish strong collaboration with global engineering and technology organisations.

· Drive alignment between local manufacturing requirements and global engineering standards.

2.14 Quality Management & Regulatory Compliance

· Ensure Process Engineering activities comply with applicable QMS and regulatory requirements.

· Ensure engineering documentation, validation records and manufacturing records are maintained appropriately.

· Support compliance with applicable medical-device manufacturing requirements and internal quality standards.

· Ensure process and equipment changes follow appropriate change-control and validation requirements.

· Promote a strong quality-by-design and prevention-based manufacturing culture.

2.15 Manufacturing Knowledge & Engineering Standards

· Establish and maintain engineering standards for Process Flow, PFMEA, Control Plans, Work Instructions, Process Parameters, Process Validation, Equipment Specifications, Automation Standards, Tooling and Fixture Standards, Process Capability and Engineering Change Management.

· Develop reusable engineering standards and lessons learned across product families and manufacturing sites.

Required Qualifications

· Bachelor’s or Master’s degree in Mechanical, Production, Manufacturing, Industrial, Mechatronics, Robotics & Automation, Electrical, Electronics Engineering or a related engineering discipline.

· Typically 12–18+ years of relevant manufacturing/process engineering experience, with significant experience in engineering leadership.

· Typically 5–8+ years of experience leading Process Engineering, Manufacturing Engineering, Industrialisation or Advanced Manufacturing Engineering teams.

· Strong experience in manufacturing process development and industrialisation.

· Demonstrated experience leading NPI, manufacturing transfer and production ramp-up.

· Strong experience in automation, equipment engineering, SPMs and manufacturing technology.

· Strong knowledge of Lean Manufacturing, Six Sigma, TPM, SPC, FMEA, DOE and structured problem solving.

· Experience with process qualification and validation.

· Strong understanding of manufacturing KPIs incl, OEE, FPY, DPU, productivity, capacity, cycle time, scrap and cost.

· Experience in engineering project management and capital investment projects.

· Experience managing engineering resources, budgets and external suppliers.

· Experience leading and developing engineering teams.

· Strong understanding of QMS requirements applicable to regulated manufacturing environments.

· Experience with digital manufacturing, IoT, analytics or automation technologies is highly desirable.

Pay: ₹35,000.00 - ₹50,000.00 per month

Work Location: In person

📌 Head - Process Engineering (Coimbatore)
🏢 MEC Groups
📍 Coimbatore