Beschreibung

Mechanical Engineer with over 16 years of experience in engineering, product development, and technical project coordination, including more than 6 years in regulated medical device environments. Experienced in supporting global medical device programs involving design controls, risk management, technical documentation, engineering change management, verification and validation support, and product lifecycle activities aligned with FDA and EU MDR requirements.

Worked extensively with cross-functional teams including Quality, Regulatory Affairs, Manufacturing, Supply Chain, Marketing, and external stakeholders to support compliant implementation of product changes and development activities. Strong experience in DHF/DMR documentation, design transfer, ECR/ECO implementation, CAPA support, change control, milestone tracking, project planning, and stakeholder communication within globally governed quality systems.

Skilled in mechanical engineering, product development, CAD support, technical documentation, and structured project execution across medical devices and engineering industries. Experienced with tools and systems including SAP, Windchill, Teamcenter, PEGA, Polarion, and Microsoft Office tools.

Known for a structured and collaborative approach, strong problem-solving abilities, and attention to quality and compliance in technically demanding environments. Passionate about contributing to innovative healthcare and engineering solutions while continuously learning and improving professionally.

Currently based in Germany and actively exploring opportunities in medical devices, engineering consulting, product development, and technical project management.

Branchenexpertise

Sprachen

Englisch
Muttersprachlich oder zweisprachig
Deutsch
Grundkenntnisse
Tamil
Muttersprachlich oder zweisprachig
Hindi
Konversationssicher

Arbeitsortpräferenzen

Vor Ort möglich

Stuttgart (bis zu 50 km), Berlin (bis zu 50 km), Frankfurt am Main (bis zu 50 km), Munich (bis zu 50 km), Hamburg (bis zu 50 km)

HCL Technologies Ltd,
Senior Technical Lead
MEDIZIN
Juni 2019 - Juli 2025 (6 Jahre und 1 Monat)
Tamil Nadu, India
Managed medical device development, sustaining engineering, remediation, and design change projects for Class IIa/IIb products in compliance with EU MDR, ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
Prepared and maintained design control and technical documentation, including design inputs, design outputs, verification and validation records, DHF/DMR documents, gap assessments, redlines, and ECR/ECO implementation records.
Supported ISO 14971 risk management activities including risk assessment, risk control definition, implementation tracking, and verification of risk control measures during design changes and remediation projects.
Supported design transfer and production implementation activities by coordinating documentation updates, design output release, manufacturing drawing updates, training inputs, and implementation through ECR/ECO processes.
Led design review and design transfer meetings with cross-functional teams, ensuring compliant documentation, decision tracking, and timely closure of actions.
Supported technical investigations related to product changes, CAPA implementation, labelling/IFU remediation, and continuous product improvement.
Managed CAD-related design output activities, including review and update of product drawings, packaging drawings, specifications, and test method fixtures.
Executed IFU labelling remediation activities to ensure compliance with UDI regulatory requirements.
RECODE Program
complete product portfolio optimization for Injection Systems.
Managed new product qualification, product migration, and obsolescence strategy. Projects
Led and executed multiple product engineering initiatives including CAPA implementation, new product qualification, and labelling remediation.
Orion Program: product design updates to comply with ISO 80369-7:2021, transitioning from ISO 594 standards.
ISO 13485 EU MDR Remediation Technical project management Change control
Caresoft Global Pvt Ltd,
Team Leader
Dezember 2015 - November 2018 (2 Jahre und 11 Monate)
Coimbatore, Tamil Nadu, India
• • Supported benchmarking and teardown analysis of electric vehicles during a three-month USA assignment.
• • Led quality review activities for CAD models, assemblies, subsystem documentation, and BOM outputs.
• • Reviewed CAD deliverables for vehicle subsystems including steering, suspension, brakes, cooling, axles, HVAC, and lighting systems.
• • Captured and reviewed material specifications, manufacturer details, and component data across multiple subsystems.
• • Managed task prioritization, resource planning, work allocation, quality review, and
delivery tracking.
• • Supported project and process documentation activities related to automotive
benchmarking program
Caresoft Global Pvt Ltd,
Associate Team Leader
Februar 2013 - August 2015 (2 Jahre und 6 Monate)
Coimbatore, Tamil Nadu, India
• • Led a team of 6+ Mechanical Design Engineers supporting new product development and
engineering change management projects.
• • Designed and developed grain storage bins, silos, hoppers, conditioning dryers, and material
handling systems.
• • Managed scope studies, task estimation, prioritization, resource planning, and work allocation ensuring timely project execution.
• • Conducted quality reviews of CAD models and manufacturing drawings against defined standards and checklists, and signed off the completed tasks/projects.
• • Managed BOM structures and engineering changes (ECR/ECO) through SAP and Windchill.
• • Trained newly onboarded engineers on customer products, engineering tools, standards, and processes. Supported projects directly from GSI Global Headquarters, USA 3
recognized customer SME