Sr Manager New Product Development

Shape the Future with Us. At Lubrizol, we’re transforming the [industry/market – link to relevant LZ business page, if applicable] through science, sustainability, and a culture of inclusion. As part of our global team, you’ll be empowered to make a real impact—on your career, your community, and the world around you. Join Our Thriving Team as a Senior Manager New Product Development – Medical Devices! How You’ll Make an Impact As a Sr. Manager, New Product Development you'll be at the forefront of our innovation, driving new product development for our Medical Device business. You'll lead, manage, and collaborate with a diverse group of passionate individuals to deliver sustainable solutions to advance mobility, improve wellbeing, and enhance modern life. In this role, you will: 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. Required Qualifications that Enables Your Success Bachelor’s degree in mechanical or biomedical engineering or related technical field. 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 Product Development Projects 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. Preferred Qualifications that Drive you Forward PMP Certification 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. Experience with Product Design using Solidworks. Your Work Environment At Lubrizol, we’re committed to providing a safe, inclusive, and empowering environment where you can do your best work—whether in a lab, on the production floor, or in a hybrid office setting. Depending on your role, your work environment may include: Standing, walking, or operating equipment for extended periods Working in a lab or manufacturing setting with appropriate PPE provided Use of computers and digital tools in an office or hybrid environment Occasional lifting or movement of materials Adherence to rigorous safety protocols and ergonomic standards We continuously invest in our facilities and technologies to ensure they support your well-being, productivity, and growth. If you require reasonable accommodation, we are committed to working with you to ensure an inclusive and accessible experience. Lubrizol: Imagined for Life. Enabled by Science.™Delivered by You. For nearly 100 years, The Lubrizol Corporation, a Berkshire Hathaway company, has been at the forefront of innovation to enhance everyday life, advance mobility, and make the modern world work better. Our specialty chemistry solutions—from engine oils, performance coatings, and skincare to medical devices and plumbing systems —are powered by the expertise, passion, and commitment of people like you. We tackle the world’s toughest challenges with science-based solutions, deeply understanding our customers to deliver innovative chemistry and differentiated value. Our inclusive culture, dedication to safety, and incredible global talent drive our success. Our solutions meet the evolving needs of the modern world—brought to life by science and, most importantly, delivered by you. Whether you're in the lab, on the production floor, or in the office, you'll be part of a team around the world that empowers you to think boldly, drive results, and contribute to solutions that shape a better, more sustainable future. We win because of you. Let’s build the future together.