Design Engineer

Job Description

Job Title

Design Engineer Medical Devices

Department

R&D Medical Devices

Location

Vapi, Gujarat

Reports To

Manager / Senior Manager Design & Development

Job Purpose

Meril Life Sciences is seeking a highly motivated Design Engineer to support the design and development of innovative Medical Devices. The role involves designing plastic molded and metal components, product enclosures, and mechanical assemblies for advanced medical devices while ensuring compliance with global quality and regulatory standards.

The ideal candidate should possess strong expertise in plastic injection molded components, precision metal parts, enclosure design, CAD modeling, and medical device product development, with a focus on manufacturability, performance, reliability, aesthetics, and cost optimization.

Key Responsibilities

1. Product Design & Development

• Design and develop mechanical components, sub-assemblies, and complete assemblies for medical devices.
• Develop innovative concepts and translate requirements into manufacturable product designs.
• Create 3D CAD models, assemblies, detailed manufacturing drawings, BOMs, and engineering documentation using SolidWorks, CATIA, or AutoCAD.
• Ensure designs meet functional, ergonomic, aesthetic, reliability, and durability requirements.
• Conduct design reviews and implement design improvements throughout the product lifecycle.
• Apply DFM (Design for Manufacturing) and DFA (Design for Assembly) principles to optimize product performance and production efficiency.

2. Plastic Injection Molded Component Design

• Design and develop plastic injection molded components for medical devices.
• Select suitable engineering polymers such as ABS, PC, PC-ABS, Nylon, PEEK, and other medical-grade materials.
• Define critical design parameters including:
• Wall thickness
• Draft angles
• Ribs and bosses
• Snap-fit mechanisms
• Parting lines
• Gate locations
• Participate in mold design reviews and tooling trials (T0, T1, T2).
• Analyze and resolve molding issues such as:
• Sink marks
• Warpage
• Shrinkage
• Flow marks
• Cosmetic defects
• Coordinate with tooling vendors and manufacturing teams for successful production implementation.

3. Precision Metal Parts Design

• Design metal components utilizing:
• CNC machining
• Turning
• Milling
• Sheet metal fabrication
• Casting processes
• Perform GD&T application and tolerance stack-up analysis.
• Select appropriate materials including:
• Stainless Steel (SS304 / SS316)
• Aluminum alloys
• Brass
• Titanium and other engineering metals
• Define surface finishing requirements such as:
• Anodizing
• Passivation
• Powder coating
• Polishing
• Electropolishing
• Work closely with suppliers and manufacturing teams to optimize quality, cost, and manufacturability.

4. Medical Device Enclosure & Housing Design

• Design functional and aesthetic enclosures, housings, and external assemblies for medical devices.
• Consider thermal management, cable routing, serviceability, user accessibility, and product safety requirements.
• Integrate mechanical designs with electronics, sensors, motors, actuators, and other subsystems.
• Ensure compliance with usability, reliability, and medical device design requirements.
• Optimize product designs for manufacturing, assembly, maintenance, and long-term performance.

5. Prototyping, Testing & Validation

• Support rapid prototyping using CNC machining, sheet metal fabrication, and 3D printing technologies.
• Conduct fit, form, and functional evaluations of prototypes.
• Participate in Design Verification (DV) and Design Validation (DVT) activities.
• Analyze test results and implement design modifications where necessary.
• Support risk management activities and design improvements based on user feedback and validation outcomes.

6. Cross-Functional Collaboration

• Collaborate with:
• Electronics Engineering
• Software Engineering
• Manufacturing Engineering
• Quality Assurance
• Regulatory Affairs
• Supply Chain teams
• Support design transfer activities from R&D to production.
• Coordinate with suppliers, toolmakers, and contract manufacturers.
• Participate in Engineering Change Order (ECO) and Change Management activities.
• Drive continuous product and process improvement initiatives.

7. Documentation & Regulatory Compliance

• Prepare and maintain engineering documentation including:
• Design drawings
• Specifications
• BOMs
• Design history records
• Revision control documents
• Support Design Control processes in compliance with:
• ISO 13485
• IEC 60601 (where applicable)
• Medical Device Quality Management Systems
• Participate in internal and external audits.
• Ensure adherence to company quality systems and applicable regulatory requirements.

Educational Qualification

• B.E. / B.Tech in Mechanical Engineering, Production Engineering, Mechatronics, Industrial Design, or related disciplines.
• Diploma holders with relevant experience may also be considered.

Experience

• 12 years of experience in mechanical product design and development.
• Experience in:
• Medical Devices
• Healthcare Equipment
• Precision Engineering Products
• Electromechanical Systems
• Industrial Product Design
• Experience with plastic molded and precision metal components is mandatory.

Technical Skills

Mandatory

• SolidWorks
• AutoCAD and/or CATIA
• Plastic Injection Molding Design
• Metal Parts Design
• GD&T
• Tolerance Stack-Up Analysis
• DFM/DFA
• BOM Preparation
• Engineering Documentation

Preferred

• Medical Device Product Development
• Enclosure & Housing Design
• FMEA
• Risk Management
• Rapid Prototyping
• ISO 13485 Design Controls
• IEC 60601 Awareness

Competencies

• Strong analytical and problem-solving skills.
• High attention to detail and design accuracy.
• Excellent understanding of manufacturing processes.
• Ability to work effectively in a cross-functional and regulated environment.
• Strong communication and technical documentation skills.
• Innovative mindset with a focus on quality, usability, and continuous improvement.

Key Performance Indicators (KPIs)

• On-time completion of design deliverables against project milestones.
• First-time-right design quality and reduction in engineering change requests.
• Successful tooling qualification and manufacturing transfer.
• Compliance with quality, regulatory, and documentation requirements.
• Contribution to product reliability, innovation, and cost optimization.
• Reduction in development cycle time and manufacturing-related issues.

Why Join Meril Life Sciences?

• Opportunity to develop next-generation medical devices for global healthcare markets.
• Exposure to advanced product development, precision engineering, and manufacturing technologies.
• Collaborative innovation-driven work environment.
• Excellent career growth opportunities within a leading MedTech organization.