Sr Manager New Product Development (Corona, CA, US, 92879)

Lubrizol Corp•Corona, CA

34d

About The Position

The Lubrizol Corporation, a Berkshire Hathaway company, is a specialty chemical company whose science delivers sustainable solutions to advance mobility, improve wellbeing and enhance modern life. Founded in 1928, Lubrizol owns and operates more than 100 manufacturing facilities, sales, and technical offices around the world and has about 8,000 employees. For more information, visit www.Lubrizol.com. We value diversity in professional backgrounds and life experiences. By enabling a consistent, unbiased, and transparent recruitment process, Lubrizol seeks to create a positive experience for candidates so we can get to know them at their best. We recognize unique work and life situations and offer flexibility, ensuring our employees feel engaged and fulfilled in every aspect of life. Join Our Thriving Team as a Senior Manager New Product Development - Medical Devices! Unleash Your Potential. At Lubrizol we're transforming the Medical Device industry and Lubrizol is looking for exceptional talent to join us on this journey. If you are ready to join an international company with talent around the world, and want to make a real impact, we want you on our team. 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.

Requirements

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.
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; 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.
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.

Responsibilities

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.