Head – Design & Development (Medical Devices)

Location: Daman

Industry:

Employment Type:

Education & Experience

• B.Tech / M.Tech in Mechanical Engineering or related discipline.
• Minimum

  15+ years

  of progressive experience in

  Product Design & Development

  , preferably in Medical Devices.
• Strong exposure to

  Solid Edge, SolidWorks, Captiva, 3D Modules, 3D Printing, Vendor Development, Product Development Lifecycle

  .

Job Summary

Design & Development (D&D) function

Key Responsibilities

1. Product Requirements & Roadmap

• Create and maintain product requirements by engaging regularly with stakeholders (business owners, sales, support teams).
• Analyze customer usage, complaints, and market indicators to define product direction.
• Maintain a product roadmap by evaluating new product ideas, tracking industry trends, and analyzing competitor products.
• Prepare and present project reports to management.

2. Product Development & Feature Delivery

• Plan and oversee

  feature development

  to ensure timely delivery.
• Work closely with engineering teams to align with requirements.
• Track development progress and resolve bottlenecks.
• Lead

  reverse engineering

  initiatives for physical, chemical, and mechanical product properties.
• Drive

  pilot production, technology transfer, and stage-wise documentation

  .

3. Quality & Compliance

• Develop

  verification & validation plans

  ; ensure execution with the quality team.
• Ensure adherence to

  ISO 13485, ISO 62304, ISO 14791

  standards and processes.
• Create and review

  Design History Files (DHF)

  , URS, specifications, and related documentation.
• Conduct

  risk analysis

  at various stages of product development.
• Engage with end-users for product validation and improvements.

4. Resource & Vendor Management

• Generate resources by researching industry best practices and identifying technology partners.
• Build and maintain strong relationships with vendors and suppliers.
• Ensure project needs are consistently met with efficient vendor development and support.

5. Cost Management

• Prepare and maintain cost files for all projects.
• Track and update project costs periodically to ensure budgetary compliance.
• Implement cost optimization initiatives across design and development activities.

6. Team Leadership & Development

• Build, mentor, and develop the

  Design & Development team

  .
• Create and maintain a

  skill matrix

  to identify competency gaps.
• Identify future product requirements and align team skills accordingly.
• Coordinate with HR and external training providers for capability building.
• Allocate work effectively among team members and resolve conflicts proactively.

7. Innovation & Continuous Improvement

• Develop new products and enhance existing ones to meet evolving market needs.
• Evaluate and adopt new technologies such as

  3D printing, additive manufacturing, CAD/CAM, and advanced prototyping

  .
• Ensure stage-wise documentation and compliance throughout the product lifecycle.

Key Skills & Competencies

• Technical:

  Solid Edge, SolidWorks, Captiva, CAD/CAM, 3D Printing, Project Costing, Vendor Development.

• Regulatory:

  Strong knowledge of ISO 13485, ISO 62304, ISO 14791, CE, WHO GMP standards.

• Leadership:

  Strategic thinking, conflict management, team building, and stakeholder management.

• Execution:

  Strong project management, documentation governance, and risk management skills.