Head of Design

Job SummaryThe Team Lead – Research & Development (R&D;) is responsible for planning, coordinating, and executing all research and product development activities for medical equipment. The role ensures that new products and product improvements are designed, developed, tested, validated, and released for production in accordance with customer requirements, applicable standards, quality systems, and project timelines.

- Product Research & Development Planning· Review customer requirements, design inputs, product specifications, and project objectives.

· Prepare project plans, development schedules, and milestone timelines.

· Define product design concepts, technical feasibility, and development strategies.

· Allocate engineering resources and assign responsibilities to team members.

· Monitor project progress and ensure timely completion of all development activities.

- Product Design & Engineering Development· Lead the design and development of new medical equipment and accessories.

· Develop detailed engineering drawings, 3D models, and product specifications.

· Prepare and review Bill of Materials (BOM), technical documents, and assembly instructions.

· Ensure product designs comply with customer requirements and regulatory standards.

· Review design modifications and implement engineering changes where required.

- Prototype Development & Validation· Coordinate fabrication and assembly of prototype models.

· Supervise prototype evaluation, testing, and validation activities.

· Analyze test results and recommend design improvements.

· Ensure prototypes meet functional, safety, and quality requirements.

· Coordinate design verification and validation before production release.

- Coordination with Departments· Coordinate with:

o Production Department – for manufacturability and process improvements.

o Quality Assurance – for design verification and validation.

o Purchase Department – for material selection and vendor development.

o Stores – for prototype materials and inventory support.

o Service Department – for product performance feedback and field issues.

o Sales & Marketing – for customer requirements and product demonstrations.

· Ensure effective communication between departments throughout the development cycle.





- Product Quality & Regulatory Compliance· Ensure all product designs comply with applicable quality standards and regulatory requirements.

· Maintain compliance with ISO quality management systems and medical device regulations.

· Participate in design reviews, risk assessments, and validation activities.

· Support internal and external quality audits.

· Maintain complete design history records and documentation.

- Engineering Documentation· Prepare and maintain:

o Engineering Drawings o Bill of Materials (BOM)

o Design Calculations o Standard Operating Procedures (SOPs)

o Work Instructions o Test Protocols o Design Verification & Validation Reports o Engineering Change Requests (ECR)

o Engineering Change Notices (ECN)

· Maintain document revision control and traceability.

- Product Improvement & Innovation· Identify opportunities for product enhancement and innovation.

· Evaluate new technologies, materials, and manufacturing methods.

· Conduct root cause analysis for design failures and customer complaints.

· Implement corrective and preventive actions (CAPA).

· Drive continuous improvement initiatives to enhance product performance, reliability, and cost efficiency.

- Budget Awareness & Cost Control· Optimize product design to reduce manufacturing costs.

· Minimize engineering rework through effective planning and design validation.

· Monitor prototype development expenses.

· Improve product value through cost-effective engineering solutions.

· Support value engineering and cost reduction initiatives.

- Team Leadership & Resource Management· Lead and supervise the R&D; engineering team.

· Allocate projects and monitor individual performance.

· Provide technical guidance, mentoring, and coaching.

· Identify training needs and facilitate skill development.

· Foster innovation, teamwork, and a high-performance work culture.

- Reporting & Documentation· Maintain project progress reports and development schedules.

· Track design changes and project milestones.

· Prepare weekly and monthly status reports for management.





· Report technical issues, project risks, and mitigation plans.

· Present project updates during management review meetings.

- Product Release & Production Support· Approve final product design for production release.

· Support pilot production and initial manufacturing.

· Resolve engineering issues during production.

· Coordinate engineering change implementation.

· Ensure smooth transfer of products from R&D; to Production.

· Provide technical support during installation, commissioning, and customer feedback analysis.

Qualifications· Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Electronics Engineering, or a related discipline.

· Master’s Degree is an added advantage.

Experience· 5–8 years of experience in Research & Development or Product Development.

· Minimum 2 years of experience in leading an R&D; or engineering team.

· Experience in the medical equipment manufacturing industry is preferred.

Key Skills· Product Design & Development

· Research & Innovation

· CAD Software (SolidWorks, AutoCAD, Creo, CATIA)

· Engineering Drawing Interpretation

· BOM Preparation & Engineering Documentation

· Project Planning & Execution

· Design Verification & Validation

· Root Cause Analysis & Problem Solving

· Team Leadership & People Management

· Knowledge of ISO 13485, GMP, and Medical Device Regulations

· Robust Communication & Cross-functional Coordination

Work Workplace· Office-based engineering environment with regular shop-floor interaction.

· Frequent coordination with Production, Quality, Purchase, Stores, Service, and Sales departments.

· Involves prototype development, testing, product validation, and continuous improvement activities.

Role PositioningReports To: R&D; Manager / Engineering Manager

Works Closely With:

· Production Department

· Quality Assurance

· Purchase Department

· Stores

· Service Department

· Sales & Marketing

· Regulatory Affairs (if applicable)

Responsible For:

· New Product Development (NPD)

· Product Enhancement Projects

· Engineering Documentation

· Prototype Development & Validation

· Design Change Management

· Technical Support to Manufacturing

· Timely Completion of R&D; Projects

· Compliance with Quality & Regulatory Requirements

📌 Head of Design (Chennai)
🏢 WEMAKE SOLUTIONS
📍 Chennai