Sr Manager New Product Development

​​Salary Range: 160,000 - 170,000 with a 10% to 15% bonus 

Job Location: Corona, CA

Job type: Full-Time

Type of role: On-Site 

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.

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.

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.