Design , R & D

Lead and manage the complete medical device design and development process.

Ensure compliance with applicable standards such as International Organization for Standardization 13485, regulatory requirements, and company procedures.

Prepare project plans, timelines, and resource allocation.

Review and approve design inputs, outputs, verification, and validation activities.

Coordinate with Regulatory, Quality, Production, and Marketing teams.

Conduct risk management activities as per International Electrotechnical Commission 14971 requirements.

Ensure Design History File (DHF) and technical documentation are maintained.

Lead design review meetings and ensure closure of action items.

Support audits, inspections, and regulatory submissions.

Develop product concepts, drawings, specifications, and prototypes.

Prepare design input and output documents.

Create 2D/3D models and engineering drawings.

Conduct feasibility studies and product testing.

Participate in verification and validation activities.

Prepare Bills of Materials (BOM) and technical specifications.

Support manufacturing during pilot production and scale-up.

Identify design improvements and cost optimization opportunities.

Ensure design changes are properly documented and controlled.