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