Validation Engineer

5 hours ago

New Delhi, 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 & DevelopmentJob 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 PathValidation Engineer → Senior Validation Engineer → Quality/Regulatory Lead → Quality Assurance Manager / Regulatory Affairs

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