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.
