Job Summary
We are seeking a highly motivated and detail-oriented Senior Engineer with 3–4 years of experience in the In Vitro Diagnostics (IVD) industry. The candidate will be responsible for supporting the design, development, validation, and lifecycle management of IVD products while ensuring compliance with applicable regulatory and quality standards.
The ideal candidate should possess strong technical expertise in diagnostic instruments, assay development, product verification & validation, and regulatory requirements applicable to medical devices.
Key Responsibilities
Product Development & Engineering
- Participate in the design and development of IVD products and diagnostic systems.
- Prepare engineering specifications, design documents, protocols, and reports.
- Conduct feasibility studies and product performance evaluations.
- Support product enhancement and continuous improvement initiatives.
- Coordinate with cross-functional teams during product development and commercialization.
Verification & Validation
- Plan and execute product verification and validation activities.
- Develop and review test protocols, reports, and traceability matrices.
- Analyze test results and prepare technical documentation.
- Investigate product failures and recommend corrective actions.
Quality & Regulatory Compliance
- Ensure compliance with:
- ISO 13485
- IVDR / IVD Regulations
- FDA 21 CFR Part 820
- IEC 62304 (if software involved)
- IEC 61010 and applicable standards
- Support internal and external audits.
- Assist in risk management activities as per ISO 14971.
- Prepare and maintain Design History Files (DHF), Device Master Records (DMR), and Technical Files.
Manufacturing & Process Support
- Provide technical support during product transfer to manufacturing.
- Assist in process validation and equipment qualification.
- Troubleshoot manufacturing and product performance issues.
- Support supplier qualification and vendor management activities.
Documentation & Reporting
- Prepare technical reports, engineering change requests (ECRs), SOPs, and work instructions.
- Maintain accurate project documentation and records.
- Present project updates to management and stakeholders.
Required Qualifications
Education
- Bachelor's or Master's Degree in:
- Biomedical Engineering
- Biotechnology
- Electronics Engineering
- Mechanical Engineering
- Instrumentation Engineering
- Life Sciences or related field
Experience
- 3–4 years of relevant experience in the IVD/Medical Device Industry.
- Experience in diagnostic instruments, reagents, assay development, or system integration.
Pay: ₹20,000.00 - ₹30,000.00 per month
Work Location: In person
