Research and Development Hardware Engineer

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.