Meril
Website:
merillife.com
Company:
https://www.linkedin.com/company/meril
Seniority: Associate
Industries: Medical Equipment Manufacturing and Medical Practices
Job details:
Job Title: Hardware Engineer – IVF – R&D
Department: Research & Development.
Location: Vapi, Gujarat
Reports To: Head – R&D
Job Purpose:
To lead the end-to-end development, integration, and deployment of IVF medical devices, ensuring seamless coordination across design, prototyping, manufacturing, and regulatory functions. The role focuses on building high-precision, reliable, and compliant electro-mechanical systems from concept to finished product while driving innovation, localization, and operational excellence.
Key Responsibilities:
1. Product Development & Engineering
• Lead complete product lifecycle development from concept (scratch) to finished goods.
• Design and engineer IVF medical devices with high precision and reliability.
• Develop system architecture integrating optical, mechanical, and electronic components.
• Drive innovation in product design aligned with clinical and market requirements.
2. Prototyping & Validation
• Develop and refine prototypes, ensuring performance and usability standards.
• Conduct design validation, testing, and verification activities.
• Optimize prototypes for manufacturability and scalability.
3. System Integration & Assembly
• Oversee assembly and integration of complex electro-mechanical systems.
• Ensure seamless interaction between subsystems (optics, electronics, mechanics).
• Lead troubleshooting during integration and system-level testing.
4. SKD Handling & Localization
• Manage SKD (Semi Knocked Down) products, including assembly and testing.
• Drive localization and indigenization initiatives for cost and supply chain optimization.
5. Process Development & Manufacturing Support
• Develop manufacturing processes, fixtures, and testing setups.
• Support production teams with process standardization and improvements.
• Ensure smooth transition from prototype to commercial production.
6. Testing, Calibration & Compliance
• Establish protocols for testing, calibration, and quality assurance.
• Ensure compliance with ISO 13485, GMP, and medical device regulatory standards.
• Maintain documentation for audits and regulatory approvals.
7. Cross-Functional Coordination
• Collaborate with R&D, QA/RA, Manufacturing, Clinical, and Commercial teams.
• Align product development with clinical requirements and market needs.
• Coordinate with vendors and external partners for components and systems.
8. Installation & Field Support
• Lead installation and trial runs of machines at local/customer sites.
• Provide technical support during initial deployments and feedback collection.
9. Continuous Improvement & Troubleshooting
• Perform root cause analysis and implement corrective/preventive actions (CAPA).
• Drive continuous improvement initiatives in design and processes.
10. Training & Team Development
• Develop and conduct technical training programs for internal teams and users.
• Mentor and manage a high-performance engineering team.
Qualifications and Experience:
• Bachelor’s/Master’s degree in Electronics, Mechanical, Mechatronics, or Biomedical Engineering.
• 4–5 years of experience in medical devices / IVF equipment / precision engineering / robotics.
• Experience in end-to-end product development and system integration.
• Exposure to regulated environments (medical devices preferred).
Skills and Competencies:
• Strong knowledge of electro-mechanical and optical system integration.
• Expertise in prototype development, testing, and validation.
• Familiarity with embedded systems, sensors, and instrumentation.
• Understanding of ISO 13485, CE, GMP compliance requirements.
• Strong problem-solving and analytical skills.
• Ability to manage cross-functional stakeholders and complex projects.
• Hands-on approach with strong execution capability.
Click on Apply to know more.
