Sr.Manager - New Product Development

Key Responsibilities:

• Drive technical aspects of new business acquisition from customers, including requirement analysis, technical presentations, and feasibility assessments.
• Engage directly with clients, technical experts, project managers, and internal teams to gather inputs and ensure aligned project scoping and cost modeling.
• Lead the end-to-end product development lifecycle — from prototyping and testing to pilot production, verification, and validation.
• Collaborate with design, quality, regulatory, and manufacturing teams to ensure successful transfer of products from concept to commercialization.
• Evaluate technical risks and propose mitigation strategies throughout the development process.
• Ensure projects comply with applicable regulatory standards (e.g., FDA, ISO, CE) relevant to pharmaceutical and surgical devices.
• Provide technical guidance and mentorship to junior engineers and development staff.

Required Candidate Profile:

• Education: Bachelor of Technology (B.Tech) in Mechanical, Biomedical, Electronics, or related field.
• Experience: Minimum of 12 years of hands-on experience in product development, preferably in the pharmaceutical or surgical/medical device industry.
• Proven ability to manage product lifecycles from concept through to validation and market readiness.
• Strong experience with prototyping tools, CAD systems, and validation methodologies.
• Excellent communication and interpersonal skills to interface with clients, cross-functional teams, and stakeholders.
• Familiarity with regulatory frameworks and documentation requirements in the healthcare domain.

Preferred Attributes:

• Master's degree or additional certifications in medical technology, project management, or quality systems (e.g., Six Sigma, PMP).
• Prior involvement in regulatory submissions or audits (US FDA, EU MDR, etc.).
• Experience working in a global team environment with exposure to international clients.