Validation Engineer

17 hours ago

bangalore, India Evolortho Tech Pvt. Ltd. Full time

Job Description: Validation&Verification Engineer/Lead – Medical Devices (Orthopaedic Implants)    ·      Company: Evolortho Tech Pvt. Ltd.·      Location: Manufacturing Facility – Bangalore·      Reporting To: QARA manager·      Department: Quality Assurance / Regulatory Compliance / Design & Development Job PurposeTo plan, execute, and document validation and verification (V&V) activities for orthopaedic implants and associated instruments to ensure compliance with ISO 13485, MDR 2017, 21 CFR Part 820 (QSR), and Indian CDSCO requirements. The engineer will ensure that products with existing predicates meet design, process, and performance equivalence through robust testing and documentation aligned with Design History File (DHF) and Device Master Record (DMR) requirements.Key Responsibilities1.      Develop and execute validation and verification (V&V) plans aligned with design inputs, risk management (ISO 14971), and regulatory requirements.2.      Conduct design verification protocols – dimensional, mechanical, fatigue, corrosion, and biocompatibility tests per ASTM and ISO standards.3.      Perform process validation (IQ/OQ/PQ) for machining, polishing, cleaning, passivation, and packaging operations.4.      Support software/tool validation where relevant (e.g., CAD/CAM, CNC, inspection systems).5.      Prepare and maintain validation protocols, reports, and traceability matrices ensuring compliance with ISO 13485 and 21 CFR 820.75.6.      Coordinate with cross-functional teams (R&D, QA, Production) and external laboratories for validation tests.7.      Assist in DHF and DMR documentation and ensure alignment with predicate device evidence.8.      Support risk management (FMEA) and CAPA implementation, ensuring revalidation where required.9.      Participate in internal/external audits (ISO 13485, CDSCO, MDSAP) and ensure readiness and closure of non-conformances. Key Skills & Competencies1.      Thorough understanding of medical device validation principles (Design, Process, Cleaning, Sterilization).2.      Knowledge of ISO 13485, ISO 14971, ISO 10993, ASTM F136/F138/F75, ISO 7206, and ISO 14242 standards.3.      Experience in protocol drafting, data analysis, and statistical tools (MSA, Cpk, GR&R, Minitab).4.      Strong documentation, analytical, and report writing skills.5.      Understanding of predicate comparison and equivalence demonstration principles.6.      Excellent coordination, communication, and audit-readiness skills.Education Qualification• Bachelor’s / Master’s Degree in Biomedical Engineering, Mechanical EngineeringExperience Required• 3–7 years of experience in medical device manufacturing or orthopaedic implant validation. • Prior experience with predicate-based devices CDSCO preferred. • Experience in design verification, process validation, and regulatory documentation is essential. • Exposure to cleanroom processes, sterilization validation, and biocompatibility test coordination desirable.Certifications (Preferred)• ISO 13485:2016 Lead Auditor / Internal Auditor• Six Sigma Green Belt (Validation & Statistical Tools)• Training in Risk Management (ISO 14971)• MDR 2017 / EU MDR Awareness TrainingCareer PathValidation Engineer → Senior Validation Engineer → Quality/Regulatory Lead → Quality Assurance Manager / Regulatory Affairs

  • Functional Validation Engineer

    5 days ago

    Bangalore, India Capgemini Engineering Full time

    Functional Validation Engineer Location: Bangalore Experience: 4–9 years Notice Period: Immediate to 30 days Choosing Capgemini means choosing a place where you’ll be empowered to shape your career, supported by a collaborative global community, and inspired to reimagine what’s possible. Join us in helping leading organizations unlock the value of...

  • Functional Validation Engineer

    1 week ago

    bangalore, India Capgemini Engineering Full time

    Functional Validation EngineerLocation: BangaloreExperience: 4–9 yearsNotice Period: Immediate to 30 daysChoosing Capgemini means choosing a place where you’ll be empowered to shape your career, supported by a collaborative global community, and inspired to reimagine what’s possible. Join us in helping leading organizations unlock the value of...

  • Validation Test Engineer

    3 weeks ago

    Bangalore, India Jobted IN C2 Full time

    Job Description Choosing Capgemini means choosing a place where you’ll be empowered to shape your career, supported by a collaborative global community, and inspired to reimagine what’s possible. Join us in helping leading Consumer Products and Retail Services (CPRS) organizations unlock the value of technology and drive scalable, sustainable growth....

  • Functional Validation Engineer

    3 weeks ago

    Bangalore Division, India Capgemini Engineering Full time

    Functional Validation Engineer Location: Bangalore Experience: 4–9 years Notice Period: Immediate to 30 days Choosing Capgemini means choosing a place where you’ll be empowered to shape your career, supported by a collaborative global community, and inspired to reimagine what’s possible. Join us in helping leading organizations unlock the value of...

  • Senior EE Validation Engineer

    19 hours ago

    bangalore, India Candidate Front Office Akka Group Full time

    General information CategoryOPERATIONS - ENGINEERING/PRODUCTION Job titleSenior EE Validation Engineer ContractPermanent contract Contractual hoursFull time Job description Build your brand. Tell your story. Take advantage of a rare opportunity to start from the ground up and build something great. We are looking for technology game changers to lead...

  • Validation Lead

    3 days ago

    Bangalore, India Zeno Full time

    Zeno is seeking a Battery Validation Lead to establish and lead validation efforts for Zeno’s battery systems. Bengaluru – Work from Office (5 days a week) Start Date: Immediate An unprecedented energy transition has begun. To meet 2040 net zero goals, over 2 billion electric two-wheelers (motorcycles) must be sold and $11 trillion in fuel consumption...

  • System Validation Engineer

    3 days ago

    bangalore, India L&T Technology Services Full time

    Role Overview:As a System Validation Engineer, you will be responsible for setting up and maintaining x86 and Chip SoC platforms for functional validation. This includes configuring hardware, software, and thermal solutions, and ensuring stable system operations across multiple environments.Key Responsibilities:- Set up x86 and Chip SoC platforms for...

  • Senior Validation Engineer

    3 days ago

    bangalore, India Ignitarium Full time

    About the PositionPosition : Senior Engineer (Post/ Pre Silicon Validation Engineer )Experience : 3 to 9 years Location : Bangalore Skills Required 1. Knowledge of one or more Protocols: PCIe, LPDDR, SPI, USB, AXI2. Knowledge of ARM and/or x86 SoC Architecture3. Strong experience in C programming language and Assembly Language.4. FreeRTOS experience5....

  • Senior Validation Engineer

    1 day ago

    Bangalore, India Ignitarium Full time

    About the Position Position : Senior Engineer (Post/ Pre Silicon Validation Engineer ) Experience : 3 to 9 years Location : Bangalore Skills Required 1. Knowledge of one or more Protocols: PCIe, LPDDR, SPI, USB, AXI 2. Knowledge of ARM and/or x86 SoC Architecture 3. Strong experience in C programming language and Assembly Language. 4. FreeRTOS experience 5....

  • Validation Engineer

    3 weeks ago

    Bangalore Division, India Ignitarium Full time

    Position : Staff Engineer - C/Embedded/Validation Years of Experience : 3 to 5 years Job Location : Bangalore / Kochi Mandatory Skills Strong experience in Coding and Development with C programming language Experience in Testing (Integration Testing) of device driver/ firmware in platforms with Linux or Any RTOS or Baremetal. Experience with Linux...