Medical Device Design Quality & Validation Engineer

Name: Mahendra

Phone Number: +1-940-***-****

Email: ********.*****@*****.***

SUMMARY:

Experienced Design Quality and Validation Engineer with around 7 expertise in regulatory standards for medical devices, including FDA 21 CFR Part 820, ISO 13485, EU MDR, ISO 14971, IEC 60601, ISO 9001 and GMP, ensuring compliance throughout the product lifecycle.

Skilled in developing and executing Master Validation Plans (MVP), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for medical device manufacturing processes and equipment.

Proficient in conducting root cause analysis (RCA) using tools such as 8D, 5 Whys, and Ishikawa diagrams to identify and address underlying issues in manufacturing, design, and quality systems.

Experienced in performing process capability analysis (Cpk/Ppk) to assess manufacturing process stability and optimize workflows for consistent product quality.

Skilled in developing and maintaining Device History Files (DHF), Device Master Records (DMR), and Device History Records (DHR), ensuring full traceability, regulatory compliance, and quality control throughout the medical device product lifecycle.

Proficient in implementing risk management strategies aligned with ISO 14971, conducting Failure Mode and Effects Analysis (FMEA) to mitigate potential risks in design and manufacturing.

Successfully utilized cross-functional teams to resolve non-conformances (NCRs) through detailed investigations and the implementation of corrective and preventive actions (CAPA).

Skilled in statistical analysis and process optimization using Six Sigma methodologies to enhance product reliability and reduce variability.

Experienced in collaborating with R&D, manufacturing, and regulatory teams to integrate quality systems into design controls, ensuring compliance with DHF/DMR/DHR requirements across the product lifecycle.

Proficient in performing Test Method Validation (TMV) to ensure accuracy and reproducibility of testing methods for medical devices.

Experienced in URS to DS translation, regulatory compliance, Test Plan design, Test Case authoring, and testing for product validation and regulatory submissions.

Extensive experience in reviewing Standard Operating Procedures (SOPs) and work instructions to ensure adherence to Good Manufacturing Practices (GMP) in medical device manufacturing.

Conducted Post-Market Surveillance (PMS) activities to monitor product performance, analyze post-market data for trends and risks, implement CAPA for continuous improvement, and ensure compliance with ISO 13485 and FDA 21 CFR Part 820, supporting regulatory submissions and maintaining market authorization.

Utilized CAD software to review and validate product designs for manufacturability and regulatory compliance, ensuring alignment with quality standards.

Managed ERP systems to streamline quality processes, track validation activities, and improve operational efficiency, supporting seamless product lifecycle management.

Conducted Design Failure Mode and Effects Analysis (DFMEA) and Process Failure Mode and Effects Analysis (PFMEA) to identify and address design and process risks, implementing corrective actions and mitigation strategies to enhance product reliability, quality, and regulatory compliance.

Technical Skills:

Regulatory Compliance & Standards

FDA 21 CFR Part 820, ISO 13485, ISO 14971, ISO 9001, EU MDR, IEC 60601,GMP, AS9100

Validation & Quality

Assurance

Master Validation Plan (MVP), IQ, OQ, PQ, Process Validation, Test Method Validation (TMV), Gage Repeatability & Reproducibility (Gage R&R), Cleaning Validation,

DFMEA, PFMEA, NCR.

Risk Management &

Root Cause Analysis

Failure Mode & Effects Analysis (FMEA), Root Cause Analysis (8D, 5 Whys, Ishikawa),

Corrective & Preventive Actions (CAPA), Gap Analysis

Statistical &Process

Optimization

Process Capability Analysis (Cpk/Ppk), Six Sigma Methodologies, CpK and PpK Analysis,

Minitab for statistical analysis, Statistical Process Control (SPC)

Quality Management

Systems (QMS)

Device History Files (DHF), Device Master Records (DMR), Device History Records (DHR),

Standard Operating Procedures (SOPs), Work Instructions (WIs), Post-Market Surveillance (PMS)

Manufacturing & Audits

Medical Device Manufacturing Processes, SMT, X-ray, Laser Welding Equipment, Regulatory Audit Preparation (FDA, ISO, Internal), Supplier Quality Management

MS Office Tools

MS Suite

Client: Monogram Orthopaedics – Austin, TX Aug 2023 - Present

Role: Design Quality /Validation Engineer

Responsibilities:

Managed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing automated orthopedic manufacturing equipment, including the MBOS Total Knee Arthroplasty (TKA) system, ensuring precise implant and instrument production.

Conducted process validation by defining Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) specifically for the MBOS TKA implant production line, ensuring consistent quality and regulatory compliance.

Executed cleaning validation protocols for surgical instruments and implants associated with the MBOS TKA system, verifying effective removal of residues to meet safety standards.

Developed and executed Test Method Validation (TMV) procedures—including both variable and attribute methods—to confirm the accuracy and precision of inspection systems used for the MBOS knee implants and associated surgical instruments.

Integrated Corrective and Preventive Actions (CAPA) into the Quality Management System (QMS), addressing nonconformances found during validation of the MBOS TKA system, and ensuring alignment with FDA 21 CFR Part 820, ISO 13485, and CGMP requirements.

Performed Gage Repeatability and Reproducibility (Gage R&R) studies on inspection tools used to measure dimensional accuracy of MBOS implant components, enhancing measurement system reliability.

Developed design verification test protocols for dimensional accuracy, functional testing, and mechanical performance of orthopedic components.

Executed design verification activities and authored comprehensive V&V reports used for design review and regulatory submissions.

Supported early-phase NPD activities by reviewing design inputs, product requirements, and risk documentation for implant and instrument development.

Collaborated with manufacturing engineering to define CTQs/CQAs for design transfer of MBOS implant components into production.

Participated in cross-functional design review meetings (P1–P5), providing quality engineering feedback on risk controls, design feasibility, and regulatory compliance.

Ensured DHF elements (design inputs/outputs, verification records, risk files) were updated throughout R&D development cycles.

Maintained Design History Files (DHFs), Device Master Records (DMRs), and Device History Records (DHRs) for MBOS TKA products within the PLM system, ensuring traceability and documentation integrity per FDA guidelines.

Supported PLM-QMS integration to improve traceability and compliance of MBOS TKA-related validation activities, including CAPAs, risk assessments (FMEA), and document control.

Conducted Root Cause Analysis (RCA) investigations for quality issues arising from MBOS TKA system validations, using tools like 5 Whys, Ishikawa diagrams, and FMEA.

Led gap analysis initiatives for MBOS-related manufacturing and validation processes to identify and resolve compliance gaps against FDA, ISO 13485, and CGMP standards.

Client: OraSure Technologies Inc – Bethlehem, PA Aug 2021 – Jul 2023

Role: Design Quality / Validation Engineer

Responsibilities:

Developed and implemented improved quality assurance protocols for the Intercept i2he™ Oral Fluid Collection Device & Assays, reducing defects and ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR regulations.

Executed Test Method Validation (TMV) for both attribute and variable test methods, ensuring measurement accuracy and compliance with FDA and ISO standards for oral fluid diagnostic assays.

Conducted capability analysis using Minitab to validate sterilization processes, ensuring alignment with ISO 14971 risk management requirements for the Intercept i2he™ collection device.

Maintained audit-ready documentation and conducted internal audits to ensure regulatory adherence, enabling successful ISO 9001, AS9100, and FDA inspections for the product.

Executed FMEA initiatives to proactively identify and mitigate potential failure modes in the collection device, improving product reliability and patient safety.

Contributed to design updates for diagnostic devices by reviewing design outputs, change notices, and engineering documentation for quality and compliance.

Investigated and managed Non-Conformance Reports (NCRs) related to the Intercept i2he™ Oral Fluid Collection Device & Assays, identifying root causes and implementing corrective actions to prevent recurrence.

Collaborated with cross-functional teams to address NCR findings, ensuring timely resolution and compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR requirements.

Ensured all NCR resolutions were validated and verified, preventing recurrence and improving overall product reliability and compliance.

Participated in design verification of diagnostic device components, supporting functional tests, sample size justification, and data analysis.

Reviewed and verified engineering drawings using GD&T standards (ASME Y14.5) to confirm accuracy and completeness before validation and production release, reducing design-related non-conformances.

Supported transfer of new assay design updates to manufacturing by validating process changes and updating PFMEAs, inspection procedures, and acceptance sampling plans.

Reviewed CAD models with R&D to ensure dimensional tolerances and GD&T schemes met design and manufacturability requirements.

Utilized GD&T principles to validate critical dimensions and tolerances in CAD drawings for the Intercept i2he™ Oral Fluid Collection Device, ensuring design intent matched functional requirements and regulatory standards.

Associated cross-functional teams in optimizing the design and manufacturing processes of the Intercept i2he™ Oral Fluid Collection Device, enhancing efficiency and reducing operational costs.

Established Good Manufacturing Practice (GMP) guidelines for production teams, ensuring adherence to regulatory expectations and consistent product quality.

Client: S M Technologies, Hyderabad - India Nov 2019 – Dec 2020

Role: Quality /Validation Analyst

Responsibilities:

Managed PFMEA assessments for implantable device manufacturing, creating and executing IQ, OQ, and PQ protocols for complex automated systems, including laser welding equipment.

Created test methods and validated measurement systems through TMV and Gage R&R documentation, ensuring inspection accuracy and repeatability.

Collaborated in FDA and third-party audits, addressing findings and ensuring ongoing compliance with FDA regulations and ISO 13485 standards.

Utilized FMEA methodologies to assess NCR trends, proactively addressing recurring issues and improving process control.

Leveraged PLM tools to manage and document engineering changes, validation protocols (IQ/OQ/PQ), and design history files (DHF) for implantable medical devices in compliance with ISO 13485 and FDA 21 CFR Part 820.

Utilized PLM systems to track and control Non-Conformance Reports (NCRs), ensuring traceability and effective documentation of CAPA actions throughout the product lifecycle.

Integrated PLM workflows for version control and change management of FMEA, PFMEA, and validation documentation, enhancing team collaboration and audit readiness.

Collaborated with cross-functional teams to analyze NCR data, optimize manufacturing processes, and enhance product quality.

Utilized FMEA analysis to identify failure modes, assess risks, and develop mitigation strategies for critical manufacturing processes.

Applied FMEA to enhance process reliability, ensuring early risk identification and corrective action implementation.

Integrated FMEA findings into validation protocols, improving process control and reducing product defects.

Collaborated cross-functionally to ensure alignment of risk-based testing with ISO 13485 and FDA regulations.

Client: Yantram MedTech, Hyderabad – India July 2018 – Oct 2019

Role: Validation / Quality Engineer

Responsibilities:

Conducted risk assessments using pFMEA and implemented mitigation strategies in compliance with ISO 14971 for medical devices.

Developed and executed IQ, OQ, and PQ validation protocols, ensuring adherence to ISO 13485:2016, IEC 62304, and FDA 21 CFR Part 820.

Designed and automated test cases, reducing validation time and improving efficiency in product development.

Authored validation reports for ISO 13485-compliant processes such as lyophilization and sterilization, achieving regulatory approval.

Performed Test Method Validations (TMV), including statistical analysis using Minitab to ensure testing accuracy and repeatability.

Assisted in CAPA investigations, root cause analysis, and corrective actions, improving quality in medical device manufacturing.

Utilized Fishbone diagrams to resolve recurring packaging defects, reducing customer complaints.

Participated in internal audits to ensure compliance with ISO 13485 and FDA regulations, maintaining up-to-date validation documentation.

Contributed to the development of Standard Operating Procedures (SOPs) and Work Instructions (WIs) to enhance Quality Management Systems (QMS).

EDUCATION:

Master’s University of Massachusetts, USA Jan 2021 – Dec 2022

Bachelors, Mechanical Engineer Andhra University, India July 2015- May 2019

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