Head of Department R&D Balloon PTCA Catheter Development (Director)

As the Head of Department R&D Balloon PTCA Catheter Development (Director) at our company in Dehradun, you will play a crucial role in leading the Research & Development team to design, develop, and test Balloon PTCA catheters. Your expertise in medical device development, polymer materials, catheter manufacturing processes, and regulatory compliance will be essential for developing next-generation balloon catheters that meet regulatory, clinical, and performance requirements. Key Responsibilities: - Lead the design, development, and optimization of Balloon PTCA catheters from concept to commercialization. - Develop and execute design verification and validation (V&V) testing for balloon catheters. - Select and evaluate suitable materials, coatings, and polymers to enhance catheter performance. - Work closely with cross-functional teams including manufacturing, regulatory, and clinical teams to ensure product feasibility and compliance. - Develop prototypes, test methods, and specifications for catheter components and assemblies. - Analyze and troubleshoot product performance issues using DOE (Design of Experiments), FMEA (Failure Modes and Effects Analysis), and statistical methods. - Ensure compliance with ISO 13485, FDA, CE, and other relevant regulatory standards for medical device development. - Collaborate with suppliers to ensure quality and scalability of catheter production. - Document and maintain design history files (DHF), risk management files, and technical reports. Qualifications & Experience: - Education: Bachelors or Masters degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or a related field. - Experience: Min 8-15 years of experience in medical device R&D, preferably in balloon catheter design and development. - Strong knowledge of balloon forming, extrusion, bonding, and catheter assembly processes. - Hands-on experience with CAD software (e.g., SolidWorks), finite element analysis (FEA), and computational modeling. - Familiarity with balloon material properties, such as nylon, PET, and polyurethane. - Knowledge of medical device regulations including FDA 21 CFR Part 820, ISO 10993, and ISO 25539-1. - Proficiency in testing and characterization of catheter balloons (compliance, burst pressure, fatigue testing, trackability, etc.). - Strong problem-solving, analytical, and project management skills. - Excellent communication and teamwork abilities. Preferred Qualifications: - Experience with balloon catheter technologies. - Understanding of angioplasty and interventional cardiology applications. - Experience with cleanroom environments and catheter manufacturing processes. - Knowledge of 3D printing and rapid prototyping for catheter components. If you are passionate about medical device innovation and looking for an opportunity to work on cutting-edge interventional cardiology products in a collaborative and innovative work environment, apply today to be part of our dynamic team. We offer a competitive salary and benefits package along with the chance for career growth in the rapidly evolving medical device industry. Thank you for considering joining us! (Note: Contact details of Ana (Anamica) are omitted as per the instructions provided.),