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 solid execution capability.

📌 Research and Development Hardware Engineer (Vapi)
🏢 Meril
📍 Vapi