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

Lubrizol Corp•Corona, CA

34d•Onsite

About The Position

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

Requirements

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

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.