Sr Manager New Product Development

About Lubrizol  
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.   

POSITION SUMMARY

The Sr 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.

Direct Reports: NPD Engineers, NPD Technicians, NPD Operators and others as needed

Work Schedule: Typically, 8:00 am to 5:00 pm M-F

Work Location: Corona, CA

KEY 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.

The preceding reflects management’s definition of essential function for this job but does not restrict the tasks that may be assigned. Management may also assign or reassign duties and responsibilities to this job at any time.

QUALIFICATIONS

To perform job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required/preferred.

• 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; 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

TRAVEL ON COMPANY BUSINESS

Travel between US sites and Germany for training on systems and processes and affect product transfers if needed.

As needed to support sales team in development of new business, customer visits and suppliers.

The above statements reflect the general details necessary to describe the principle functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.

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.