Work Preference
Summary
Overview
Work History
Education
Skills
Certification
Languages
Key Medical Device Programs
Timeline
Generic
Sanalkumar Ayilalath
Open To Work
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Sanalkumar Ayilalath

Bengaluru

Work Preference

Job Search Status

Open to work
Desired start date: Flexible

Desired Job Title

Assistant Engineering ManagerSenior Project EngineerNPI-Process EngineerMould Maintenance TechnicianGroup Leader (Precision Tooling Division)

Work Type

Full TimeConsulting

Location Preference

HybridRemote
Location: Bengaluru, INKochi, KL
Open to relocation: Yes

Important To Me

Work-life balanceCompany CulturePersonal development programsHealthcare benefits

Summary

  • Experienced Engineering Professional with 15+ years in tooling, injection molding, and process development, device assembly and testing for the medical device industry. Expert in new product introduction (NPI), process validation, and scientific molding under ISO 13485 and cGMP standards. Certified Lean Six Sigma Green Belt & ISO 13485:2016 Internal Auditor (TUV SUD), specializing in continuous improvement, project management process optimization, and risk management. Skilled in tooling design, DOE, mold-flow analysis, and collaborating with global suppliers and customers. Known for driving process efficiency, product quality, and cost optimization in regulated manufacturing environments.

Overview

15
15
years of professional experience
6
6
Certification

Work History

Assistant Engineering Manager

SMC LTD
Bengaluru
06.2025 - Current
  • Lead engineering teams across NPI, sustaining, and manufacturing; manage resources and performance development.
  • Drive collaboration with QA/RA, R&D, Production, Supply Chain, suppliers, and customers.
  • Review and approve engineering documents, ECOs, drawings, and technical reports.
  • Lead RCA, CAPA, and advanced problem-solving for complex manufacturing issues.
  • Oversee test method development and equipment qualification (IQ/OQ/PQ).
  • Ensure compliance with ISO 13485, FDA 21 CFR 820, EU MDR, and internal QMS.
  • Lead risk management activities per ISO 14971 throughout product lifecycle.
  • Support regulatory inspections, audits, and supplier audits.
  • Drive continuous improvement using Lean, Six Sigma, DOE, and statistical tools.
  • Support budgeting, CapEx planning, and cost optimization initiatives.Lead and mentor engineering teams across NPI, sustaining, and manufacturing functions; manage resource allocation and workload.
  • Provide technical guidance, performance evaluation, and competency development for engineering staff.
  • Drive cross-functional collaboration with QA/RA, Production, R&D, Supply Chain, and suppliers.
  • Present project updates, risk assessments, and performance metrics to leadership.
  • Review and approve engineering documents, drawings, technical reports, and ECOs.
  • Lead advanced problem solving, RCA, and CAPA implementation to resolve complex technical issues.
  • Oversee test method development, validation, and equipment qualification (IQ/OQ/PQ).
  • Ensure engineering compliance with ISO 13485, FDA 21 CFR 820, EU MDR, and internal QMS requirements.
  • Lead risk management activities in accordance with ISO 14971 throughout the product lifecycle.
  • Support internal/external audits, regulatory inspections, and supplier audits.
  • Engage with customers for technical discussions, complaint investigations, and product improvements.
  • Oversee sustaining engineering, including product updates, yield improvement, and cost optimization.
  • Drive CI initiatives using Lean, Six Sigma, DOE, and statistical analysis tools.
  • Contribute to budget planning, CapEx proposals, and engineering resource management.

Senior Project Engineer

SMC LTD
Bengaluru
09.2020 - 05.2025
  • Coordinate customer and vendor interactions to align technical requirements and project objectives.
  • Drive stakeholder communication to ensure schedule adherence and milestone delivery.
  • Develop and maintain project schedules in MS Project, tracking critical path and deliverables.
  • Review and provide feedback on engineering drawings, specifications, procedures, and tooling for DFM/DFA improvement.
  • Present project status, risks, and metrics to senior leadership for decision support.
  • Participate in internal audits (Auditor/Auditee) ensuring QMS compliance.
  • Contribute to design reviews and technical meetings with data-driven engineering inputs.
  • Support pFMEA and oversee V&V strategies, test execution and documentation.
  • Lead supplier issue investigations, root-cause analysis, and CAPA implementation.

NPI-Process Engineer

Univac Precision Engineering Pte Ltd
Singapore
08.2016 - 07.2020
  • Develop robust manufacturing processes to ensure optimal tool performance to support consistent mass production output.
  • Apply scientific molding principles and Design of Experiments (DOE) methodologies to accelerate product development and optimize process performance.
  • Conduct First Article Testing (FAT) to verify part quality, dimensional accuracy, and tool functionality in compliance with customer specifications.
  • Resolve technical challenges in sustaining programs to maintain product quality and minimize downtime.
  • Prepare and execute comprehensive validation protocols; author detailed IQ/OQ/PQ (IOPQ) reports ensuring regulatory compliance and process validation integrity.

Mould Maintenance Technician

Univac Precision Pte Ltd
Singapore
03.2015 - 07.2016
  • Preparation production molds as per the production schedule.
  • Perform preventive and predictive maintenance of production molds.
  • Control of Mold Spare Elements.
  • Work with design and production team for continuous improvement on mold performance.
  • Align with NPI team on new tool qualification process.

Group Leader (Precision Tooling Division)

Konzert Toolings
Pune
07.2011 - 05.2015
  • Lead, mentor, and supervise toolmakers, machinists, designers, and technicians.
  • Allocate daily tasks and manage manpower to meet production and project timelines.
  • Ensure adherence to safety practices, 5S, and disciplined work culture.
  • Supervise mold and tool assembly according to technical drawings and specifications.
  • Lead tool tryouts, T0-Tn, to validate tool performance, part quality, and cycle time.

Education

B.Tech - Mechanical

IIMT
Gujarat
01.2021

Diploma - Tool & Die Engineering

Kerala Government Poly Technic College
01.2010

Skills

  • Project management
  • Medical device manufacturing
  • Injection moulding expertise
  • Engineering change management
  • Design of experiments
  • Customer engagement strategies
  • Resource allocation
  • Regulatory compliance
  • Budgeting and estimating
  • Risk management
  • Supplier development
  • New product development
  • Internal auditing
  • Communication skills
  • Lean Six Sigma methodology
  • Current Good Manufacturing Practices (CGMP)
  • Microsoft Project proficiency
  • Sustaining engineering practices
  • Process failure mode and effects analysis (pFMEA)
  • Design for manufacturability (DFM)
  • Verification and validation processes
  • Process development and validation

Certification

  • Internal Auditing for Quality Management System for Medical Devices based on ISO 13485:2016- TUV SUD
  • Systematic Molding/ Decouple Workshop-RJG
  • Train the Trainer- Singapore Polytechnic
  • Business Writing Skills
  • MS Project
  • Decision Making and Strategic Thinking of Leaders
  • Lean Six Sigma Green Belt from TUV SUD
  • Lean Six Sigma- Green Belt
  • ISO 13485 Certified Internal Auditor

Languages

  • English
  • Hindi
  • Malayalam
  • Tamil
  • Kannada

Key Medical Device Programs

  • HI-VNI Nasal Cannula
  • Disposable Patient Circuits (HVT 2.0 / ADPC)
  • Apheresis Systems (Trima & Spectra)
  • Needle-Free Injection Systems
  • Arthroscopy Cannula
  • Contraceptive Implant

(Roles included NPI, validation, tooling, V&V, risk management, and sustaining support.)

Timeline

Assistant Engineering Manager

SMC LTD
06.2025 - Current

Senior Project Engineer

SMC LTD
09.2020 - 05.2025

NPI-Process Engineer

Univac Precision Engineering Pte Ltd
08.2016 - 07.2020

Mould Maintenance Technician

Univac Precision Pte Ltd
03.2015 - 07.2016

Group Leader (Precision Tooling Division)

Konzert Toolings
07.2011 - 05.2015

B.Tech - Mechanical

IIMT

Diploma - Tool & Die Engineering

Kerala Government Poly Technic College

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Sanalkumar Ayilalath