Mudassar Inamdar
Pune
Summary
Accomplished Systems Engineer with over 7 years of experience in the healthcare and pharmaceutical domains, specializing in system integration, verification and validation (V&V), and product quality assurance. Expertise in ISO 13485 and ISO 14971, complemented by hands-on experience with the V-Model for V&V, system-level risk management (DFMEA), requirements engineering, and test method development. Proven track record in designing and executing robust test protocols, conducting root cause analysis, and supporting end-to-end system lifecycle activities to ensure compliant, high-quality product delivery. A commitment to excellence drives the ability to enhance product performance while adhering to industry standards.
Overview
7
7
years of professional experience
Work History
Senior System Engineer
Philips Healthcare | Onward Technologies |
12.2022 - Current
- Lead system-level verification and validation activities for power toothbrushes, chargers, and accessories to ensure compliance with product requirements and quality standards.
- Develop and execute V&V test plans, protocols, and test methods, and analyze test results to confirm product performance and reliability.
- Support system integration efforts by verifying hardware, electronics, and accessory interactions across multiple product configurations.
- Identify design and verification issues during testing and perform root cause analysis (RCA) to support timely defect resolution.
- Prepare, review, and maintain verification documentation, including test plans, test reports, qualification records, and technical memos.
- Apply statistical techniques (e.g., Gage R&R, sample size selection) to develop robust test strategies and improve measurement confidence.
- Collaborate with cross-functional teams (Design, Manufacturing, Quality, Suppliers, and Test Labs) to coordinate testing and resolve system-level issues.
- Support risk management activities by contributing to DFMEA and ensuring verification coverage for identified risks.
- Manage verification execution within project timelines, supporting on-time system releases and business commitments.
- Mentor junior engineers and technicians, providing guidance on test execution, documentation practices, and systems engineering fundamentals.
Engineer
Glatt Systems Pvt. Ltd.
10.2020 - 11.2022
- Worked as a System Validation Engineer in the Automation domain, supporting validation of pharmaceutical and food manufacturing process systems.
- Prepared and executed qualification documentation including DQ, IQ, OQ, and PQ, along with core validation deliverables such as Quality Project Plans, Instrument Lists, SOPs, and test manuals.
- Developed and executed automation and software validation protocols for regulated pharmaceutical systems in compliance with GAMP 5 (Category 4), 21 CFR Part 11, and EU Annex 11.
- Performed Computer System Validation (CSV) using a risk-based approach, ensuring data integrity and regulatory compliance across the system lifecycle.
- Supported IFAT and on-site validation activities, coordinating with Quality, Software Development, and site teams to verify system functionality and performance.
- Managed change control, deviations, CAPA, and validation documentation updates, ensuring alignment with Quality Management System (QMS) processes.
- Conducted requirements review and traceability, ensuring consistency between user requirements, functional specifications, and validation test cases.
Officer
Randen Engineering Pvt Ltd
01.2019 - 10.2020
- Reviewed and interpreted RFQs, technical specifications, drawings, and performance requirements for industrial equipment and systems.
- Selected suitable technical solutions and equipment configurations based on application needs, operating conditions, and applicable standards.
- Performed preliminary technical evaluations, including capacity calculations, material selection checks, and basic process feasibility assessments.
- Prepared technical cost estimates by analyzing raw materials, consumables, fabrication requirements, and subcontracted technical activities.
- Developed technical proposal documentation, including scope definitions, technical assumptions, and compliance statements against customer requirements.
- Supported engineering coordination activities, working with design, manufacturing, and procurement teams to confirm technical feasibility.
- Provided technical clarifications during project handover and execution, assisting in resolving design or specification-related issues.
Education
Mechanical Engineering
Al Ameen Collage of Engineering
Pune, India01-2017
Diploma - Mechanical Engineering
Pillai Polytechnic
Panvel, India01-2011
HSC -
Shree Mulikadevi Vidya Mandir
Nighoj, India01-2008
SSC -
Shree Mulikadevi Vidya Mandir
Nighoj, India01-2006
Skills
- Medical Device Risk Management (ISO 14971)
- Verification & Validation (V-Model)
- System-Level Risk Management (DFMEA)
- Test Method Development & Validation
- Test Protocol Development & Execution
- Requirements Engineering
- Six Sigma Yellow Belt
- Root Cause Analysis (RCA)
Additional Information
Fathers Name: Hanif Yusuf Inamdar.
Date of Birth: 6th April 1991.
Marital Status: Married
Activities: DIY Electronics, Gardening, Playing cricket
Languages
English
Advanced (C1)
Marathi
Bilingual or Proficient (C2)
Hindi
Advanced (C1)
Timeline
Senior System Engineer
Philips Healthcare | Onward Technologies |
12.2022 - Current
Engineer
Glatt Systems Pvt. Ltd.
10.2020 - 11.2022
Officer
Randen Engineering Pvt Ltd
01.2019 - 10.2020
HSC -
Shree Mulikadevi Vidya Mandir
SSC -
Shree Mulikadevi Vidya Mandir
Mechanical Engineering
Al Ameen Collage of Engineering
Diploma - Mechanical Engineering
Pillai Polytechnic
Hobbies
DIY Electronics, Gardening, Playing cricket