Mechanical Engineer

Job Title:

Mechanical Engineer – R&D Neonatal Devices.

Department:

Manufacturing – Neonatal Division (Genesis).

Location:

Vapi, Gujarat.

Reports To:

Manager / Senior Manager – R&D/Production.

Job Purpose:

To design and develop plastic molded and metal components for neonatal medical devices including Neonatal Incubators, Infant Radiant Warmers, Phototherapy Units, Bubble CPAP Systems, Infant Resuscitators, Physiological Monitors, and associated neonatal consumables, ensuring high standards of functionality, reliability, manufacturability, aesthetics, and regulatory compliance in alignment with global medical device standards.

Key Responsibilities:

1. Product Design & Development

• Support day-to-day assembly operations of neonatal devices and sub-assemblies.

• Ensure correct assembly sequence, torque values, alignment, and fitment as per ISO.

• Create concept, preliminary and detailed designs using SolidWorks / AutoCAD / CATIA.

• Troubleshoot mechanical assembly issues, recurring defects, and production bottlenecks.

Prepare 3D CAD models, assemblies, 2D manufacturing drawings, BOMs and technical specifications.

• Ensure designs meet functional, ergonomic, aesthetic and durability requirements.

2. Plastic Molding Design

• Design plastic injection moulded components considering material behaviour, tooling constraints and production feasibility.

• Select suitable materials such as ABS, PC, PC-ABS, Nylon, PEEK based on application requirements.

• Define wall thickness, draft angles, ribs, bosses, snap-fit features and parting lines.

• Participate in mold design reviews, tool trials (T0/T1/T2) and design modifications.

• Identify and resolve moulding issues including warpage, sink marks, shrinkage and cosmetic defects.

3. Metal Parts Design

• Design precision metal parts using machining, sheet metal, casting and turning processes.

• Apply GD&T and tolerance stack-up analysis to ensure proper fit and function.

• Select materials such as Stainless Steel (SS 304/316), Aluminium alloys, Brass.

• Define surface treatments including passivation, anodizing, polishing and coating as required.

• Coordinate with vendors and manufacturing teams for feasibility and cost optimization.

4. Physiological Monitoring Enclosure & Housing Design

• Design outer enclosures and housings for medical imaging systems.

• Consider thermal management, EMI/EMC requirements, cable routing and serviceability.

• Integrate mechanical designs with electronics, sensors and cabling.

• Ensure compliance with safety, usability and service access requirements.

5. Prototyping, Testing & Validation

• Support prototyping activities using CNC machining and 3D printing.

• Participate in fit, form and functional testing of components and assemblies.

•Support design verification and validation activities.

• Implement design changes based on testing outcomes, risk assessments and user feedback.

6. Cross-Functional Collaboration

• Collaborate with Electronics, Manufacturing, Quality, Regulatory and Supply Chain teams.

• Support design transfer activities from R&D to manufacturing.

• Participate in technical discussions with suppliers, toolmakers and manufacturing partners.

• Support engineering change management and continuous improvement initiatives.

7. Documentation & Compliance

• Prepare and maintain design documentation including drawings, specifications and revision history.

• Support design control documentation in line with ISO 13485 requirements.

• Ensure compliance with applicable medical device standards and internal quality systems.

• Participate in internal and external audits as required.

Qualifications and Experience:

• B.E. / B. Tech / Diploma in Engineering / Production Engineering or equivalent.

• 2–4 years of experience in mechanical design of plastic and metal components.

• Experience in medical devices, endoscopy, imaging systems or precision equipment preferred.

• Hands-on experience with SolidWorks / AutoCAD / CATIA is mandatory.

Skills and Competencies:

• Strong expertise in plastic injection moulding and metal part design.

• Good understanding of GD&T, tolerance analysis and manufacturing processes.

• Strong analytical, problem-solving and design optimization skills.

• High attention to detail and design accuracy.

• Ability to work effectively in a regulated, cross-functional environment.

• Good communication and technical documentation skills.

Key Performance Indicators (KPIs):

• On-time delivery of design outputs as per project timelines.

• First time-right design quality and reduction in rework or tooling changes.

• Successful transfer of designs to manufacturing with minimal issues.

• Compliance with quality and regulatory requirements.

• Contribution to cost optimization, product reliability and design improvements.