Sr.Manager - New Product Development

As a Senior Technical Product Development Manager at our company, you will play a crucial role in driving new business acquisition by handling various technical aspects. Your responsibilities will include: - Conducting requirement analysis, technical presentations, and feasibility assessments for potential customers. - Engaging directly with clients, technical experts, project managers, and internal teams to gather inputs and ensure project scoping and cost modeling alignment. - Leading the end-to-end product development lifecycle - from prototyping and testing to pilot production, verification, and validation. - Collaborating with design, quality, regulatory, and manufacturing teams to facilitate the successful transfer of products from concept to commercialization. - Evaluating technical risks and proposing mitigation strategies throughout the development process. - Ensuring project compliance with relevant regulatory standards such as FDA, ISO, and CE for pharmaceutical and surgical devices. - Providing technical guidance and mentorship to junior engineers and development staff. Qualifications required for this role: - Education: Bachelor of Technology (B.Tech) in Mechanical, Biomedical, Electronics, or a related field. - Experience: Minimum of 12 years hands-on experience in product development, preferably in the pharmaceutical or surgical/medical device industry. - Proven track record of managing product lifecycles from concept to validation and market readiness. - Strong proficiency in prototyping tools, CAD systems, and validation methodologies. - Excellent communication and interpersonal skills to effectively interact with clients, cross-functional teams, and stakeholders. - Familiarity with regulatory frameworks and documentation requirements in the healthcare domain. Preferred attributes that would be beneficial for this role: - Master's degree or additional certifications in medical technology, project management, or quality systems (e.g., Six Sigma, PMP). - Prior experience with regulatory submissions or audits (US FDA, EU MDR, etc.). - Experience working in a global team environment with exposure to international clients. In addition to the above requirements, the ideal candidate should possess skills in PMP, Six Sigma, and FDA regulations. Your expertise in these areas will be instrumental in successfully fulfilling the responsibilities of this role. As a Senior Technical Product Development Manager at our company, you will play a crucial role in driving new business acquisition by handling various technical aspects. Your responsibilities will include: - Conducting requirement analysis, technical presentations, and feasibility assessments for potential customers. - Engaging directly with clients, technical experts, project managers, and internal teams to gather inputs and ensure project scoping and cost modeling alignment. - Leading the end-to-end product development lifecycle - from prototyping and testing to pilot production, verification, and validation. - Collaborating with design, quality, regulatory, and manufacturing teams to facilitate the successful transfer of products from concept to commercialization. - Evaluating technical risks and proposing mitigation strategies throughout the development process. - Ensuring project compliance with relevant regulatory standards such as FDA, ISO, and CE for pharmaceutical and surgical devices. - Providing technical guidance and mentorship to junior engineers and development staff. Qualifications required for this role: - Education: Bachelor of Technology (B.Tech) in Mechanical, Biomedical, Electronics, or a related field. - Experience: Minimum of 12 years hands-on experience in product development, preferably in the pharmaceutical or surgical/medical device industry. - Proven track record of managing product lifecycles from concept to validation and market readiness. - Strong proficiency in prototyping tools, CAD systems, and validation methodologies. - Excellent communication and interpersonal skills to effectively interact with clients, cross-functional teams, and stakeholders. - Familiarity with regulatory frameworks and documentation requirements in the healthcare domain. Preferred attributes that would be beneficial for this role: - Master's degree or additional certifications in medical technology, project management, or quality systems (e.g., Six Sigma, PMP). - Prior experience with regulatory submissions or audits (US FDA, EU MDR, etc.). - Experience working in a global team environment with exposure to international clients. In addition to the above requirements, the ideal candidate should possess skills in PMP, Six Sigma, and FDA regulations. Your expertise in these areas will be instrumental in successfully fulfilling the responsibilities of this role.