Sr Manager New Product Development

The Sr Manager New Product Development will lead Lubrizol’s medical device contract design and development department, managing a team and developing a sustainable medical device design and development operation.

Requirements

• Bachelor’s degree in mechanical or biomedical engineering or related technical field
• Minimum 5 years of experience in in design and manufacture of medical devices preferably within New Product Development (NPD) in a regulated industry
• Ability to lead cross-functional teams and drive NPD projects from concept to market under regulatory constraints
• Strong project management skills, ideally supported by a certification such as PMP (Project Management Professional)
• In-depth knowledge of FDA regulations and ISO 13485, especially regarding design and documentation requirements in the context of product development
• Clinical understanding of minimally invasive technologies, including catheter delivery systems
• Technical expertise in catheter manufacturing processes, including thermoplastic extrusion, braiding, assembly techniques and balloon forming
• Solid foundation in polymer science and plastics engineering
• Familiarity with cleanroom standards and GMP-compliant production environments
• Experience in transferring products from R&D to production
• Proficiency in CAD tools, especially SolidWorks
• Strong leadership skills with the ability to motivate and direct cross-functional teams
• Excellent verbal and written communication skills
• Highly innovative, motivated, detail-oriented, diligent, and organized
• Ability to thrive in a fast-paced, dynamic environment
• Strong business acumen and strategic thinking
• A collaborative team player with a proactive, ‘can-do’ attitude