Sr Manager New Product Development

The Senior Manager New Product Development will lead Lubrizol’s medical device contract Design and Development Department. The Sr Manager NPD will have full responsibility for managing the department and employees and will be accountable in developing a sustainable medical device design and development operation. The role involves also establishing, maintaining, and continuously enhancing the infrastructure, departmental structure, systems, facilities, and equipment necessary to support operational and strategic objectives. What You'll Do: - Lead a multidisciplinary team of NPD engineers and support staff to deliver customer projects on time, within budget, and to quality standards. - Collaborate with Quality to implement and maintain finished device quality systems aligned with FDA and CE requirements, including design controls, product testing, and validation. - Prepare and present comprehensive project proposals to customers, covering scope, costing, timelines, deliverables, and services. - Act as primary technical interface with customers and Sales to define product design requirements and assess internal manufacturing capabilities. - Oversee the creation and management of project documentation, including product specifications, pFMEAs, validation protocols and reports, manufacturing procedures, BOMs, and routers. - Support regulatory documentation efforts, including design history files, CE marking, and FDA submissions. - Define and execute validation protocols for processes, products, and equipment in collaboration with Quality. - Drive the NPD process to ensure products are designed for manufacturability, cost-efficiency, and quality, including conducting DFM reviews and resolving production challenges. - Coordinate cross-functional handover of product designs from NPD to manufacturing, ensuring seamless transfer and preservation of design intent during scale-up and launch. - Collaborate with global NPD teams to facilitate product and knowledge transfer across R&D and NPD sites. Skills That Make a Difference: - Bachelor’s degree in mechanical or biomedical engineering or related technical field. - Minimum 5 years of experience in design and manufacture of medical devices preferably within New Product Development (NPD) in a regulated industry. - Experience leading product design teams including hands-on product design (SolidWorks is a plus). - Strong experience leading Projects (PMP is a plus). - In-depth knowledge of FDA regulations and ISO 13485, especially regarding design and documentation requirements in the context of product development; certification or formal training in ISO 13485 or FDA 21 CFR Part 820 is preferred. - 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. - Experience with  cleanroom standards and GMP-compliant production environments. - Experience in transferring products from R&D to production. Ready for your next career step? Apply today and let's shape the future together! It’s an exciting time to be part of Lubrizol. Lubrizol is not staying put. We are continually learning and evolving. Our passion delivers our success — not only for Lubrizol but for those who count on us every day: our employees, customers and communities. We work with a relentless commitment to operate safely and responsibly, keeping safety, sustainability, ethics, and compliance at the forefront of everything we do. The well-being of our employees, customers and communities is paramount to our culture and in the way we approach our work. As a diverse, global team, we work together to solve some of the world’s most pressing challenges. We impact everyday lives through science only Lubrizol can deliver, and we never stop pushing to do it better. One of the founding principles of The Lubrizol Corporation more than 90 years ago was treating every employee with dignity and respect. That same commitment is only stronger today. More than that, we are committed to providing an environment where every employee can be the best they can be, no matter their race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veteran status or any other characteristic.