The Lubrizol Corporation · 2 hours ago
Sr Manager New Product Development
Corona, CA
Full-time
Onsite
Senior Level
$160K/yr - $170K/yr
5+ years expThe Lubrizol Corporation is a specialty chemical company focused on advancing mobility and improving wellbeing. They are seeking a Senior Manager for New Product Development in the Medical Devices sector to lead a multidisciplinary team, manage projects, and ensure compliance with regulatory standards.
ChemicalInformation TechnologyManufacturingMedicalMedical Device
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
Qualification
Required
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
Experience leading product design teams including hands-on product design (SolidWorks is a plus)
Strong experience leading Projects (PMP is a plus)
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
Experience with cleanroom standards and GMP-compliant production environments
Experience in transferring products from R&D to production
Company
The Lubrizol Corporation
The Lubrizol Corporation, a Berkshire Hathaway company, is a science-based company whose specialty chemistry delivers sustainable solutions to advance mobility, improve well-being and enhance modern life.
5001-10000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2011-03-15Acquired
Leadership Team
Rebecca Liebert
President and CEO
Keith Corkwell
President, Lubrizol Additives
Recent News
2025-12-08
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