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Assistant Manager – Stent Division

3 months ago

Mysuru, India The Edge Partnership Full time

Key responsibilities

Lead the design, prototyping, and testing of new stent products. Collaborate closely with R&D and engineering teams to refine product concepts and specifications. Manage multiple projects to ensure adherence to timelines and budgets. Develop and maintain detailed project plans, schedules, and reports. Utilize advanced knowledge of stent design, materials, and manufacturing processes to troubleshoot technical challenges and maintain product quality. Work with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing. Communicate project progress, address challenges, and identify opportunities to senior management. Ensure all new products meet regulatory standards and guidelines. Prepare and review technical documentation for regulatory submissions. Drive continuous improvement initiatives by identifying process enhancements and implementing best practices in product development to foster innovation.

Role requirements

Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or a related field. 4 to 5 years of experience in medical device product development, with a focus on micro catheters. Proven track record of managing successful product development projects. Strong technical skills in catheter design and manufacturing processes. Excellent problem-solving abilities and attention to detail. Effective communication and leadership skills. Knowledge of regulatory requirements for medical devices (e.g., FDA, CE). Ability to work in a fast-paced, dynamic environment.

Preferred Skills:

Experience with CAD software and other design tools. Knowledge of material science and biocompatibility. Understanding of quality systems and standards (e.g., ISO 13485).