Research and Development Hardware Engineer

Meril; Vapi; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Meril is seeking a Hardware Engineer - IVF - R&D to lead end-to-end product development of IVF medical devices. You will design, prototype, validate, and integrate electro-mechanical and optical systems, coordinating across design, prototyping, manufacturing, and regulatory teams to ensure compliant, high-precision solutions.

You will drive innovation, localization, and process improvements, overseeing field deployments and CAPA actions while mentoring a growing engineering team.

Qualifications

• Bachelor’s/Master’s degree in Electronics, Mechanical, Mechatronics, or Biomedical Engineering.
• Experience in end-to-end development of medical devices/IVF equipment.
• Exposure to regulated environments (medical devices preferred).

Responsibilities

• Lead end-to-end development from concept to finished goods.
• Design and engineer IVF medical devices with high precision and reliability.
• Develop system architecture integrating optical, mechanical, and electronic components.
• Drive localization and indigenization initiatives for cost and supply chain optimization.
• Develop manufacturing processes, fixtures, and testing setups; support production teams.

Skills

Electro-mechanical integration

Optical system integration

Prototype development

Testing & validation

Embedded systems

Regulatory knowledge (ISO 13485/CE/GMP

Education

Engineering degree (electronics/mechatronics/biomedical)

Job description

Job Title: Hardware Engineer - IVF - R&D

Department: Research & Development.

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:

• 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.
• 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.
• 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.