Validation Engineer

3 hours ago

Bengaluru Karnataka India, Karnataka 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 Purpose

To 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 Responsibilities

1. 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 & Competencies

1. 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 Engineering

Experience 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 Training

Career Path
  • Validation Engineer → Senior Validation Engineer → Quality/Regulatory Lead → Quality Assurance Manager / Regulatory Affairs

  • Validation Engineer

    3 hours ago

    Bengaluru, Karnataka, India, Karnataka Ignitarium Full time

    About Company Ignitarium is a Silicon and Embedded System design house, formed with the vision to provide innovative, optimal and relevant solutions for enabling and assisting their customers in product development. Ignitarium is built around a core team of technologists, who share a collective industry experience of over 150 years with expertise in system...

  • Validation Head

    3 hours ago

    Bengaluru, Karnataka, India, Karnataka NMS Consultant Full time

    Job Description:-Responsible for overseeing all validation and compliance activities within an organization, ensuring that processes, systems, and equipment meet regulatory and quality standards. Key duties include developing validation master plans, managing validation lifecycles, leading a team, collaborating with other departments, and ensuring compliance...

  • System Validation Engineer

    3 hours ago

    Bengaluru, Karnataka, India, Karnataka 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...

  • SSD Validation Engineer

    3 hours ago

    Bengaluru, Karnataka, India, Karnataka Toshiba Software Pvt. Ltd. Full time

    SSD Validation EngineerLocation: BengaluruExperience: 5-8 yearsPreferred Skills:SSD domain expertise.Expertise in SSD Firmware development or SSD Validation(EVT, DVT).High level competency in NVMe and/or PCIe specification.Programing Java/C++/C/PythonExperience in SSD FW failure analysis. Root cause analysis is added advantageKnowledge of OCP, ZNS, MFND,...

  • Senior Validation Engineer

    3 hours ago

    Bengaluru, Karnataka, India, Karnataka 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....

  • Post silicon validation

    3 hours ago

    Bengaluru, Karnataka, India, Karnataka ACL Digital Full time

    Profile: Post Silicon Validation EngineerJob Description:The Validation Engineer will work on IP/system level test case development, execution and debug for automotive systems.Responsibilities:➢ Work on development and execution of validation test plans and testcases written in embedded-C and debug in post-silicon environments.➢ Be able to do proper...

  • Validation Engineer

    2 weeks ago

    Bengaluru, Karnataka, India LTIMindtree Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Hello FolksHope you are doing well Greetings from LTIMindtreeCurrently we are hiring for Validation EngineerRole : Validation EngineerExperience : 3-5 YearsLocation : Bangalore/HyderabadNotice period : Immediate and Serving Notice PeriodAbout the role :We are looking for a highly skilledServer & Storage Validation Engineerwith strong expertise in...

  • Battery Validation Lead

    3 hours ago

    Bengaluru, Karnataka, India, Karnataka Zeno Full time

    Zeno is seeking a Battery Validation Lead to establish and lead validation efforts for Zeno’s battery systems. Location: Bengaluru – Work from Office (5 days a week)Start Date: ImmediateAbout ZenoAn 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...

  • Validation Engineer

    5 days ago

    Bengaluru, Karnataka, India Pharmaval Full time ₹ 4,20,000 per year

    Job SummaryThe Validation Engineer must background in developing life-cycle documents for equipment, process and utility equipment's supporting API & Formulation operation in pharma domain . The person is responsible for the development of documents as part of validation deliverables for a project. In execution of these responsibilities, the Quality...

  • Senior Validation Engineer

    1 week ago

    Bengaluru, Karnataka, India Texas Instruments Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    *Job DescriptionChange the world. Love your job.*The Validation Engineers at Texas Instruments are powered by a passion for continual improvement. Our solutions make a real difference and yours will, too. We make the semiconductor product design process easier and faster, which helps our customers succeed in today's fast-paced marketplace.*Job...