Apply on Employer Site

The Lubrizol Corporation · 3 hours ago

Sr Manager New Product Development

Corona, CA

Full-time

Onsite

Senior Level

$160K/yr - $170K/yr

5+ years exp

The Lubrizol Corporation is a specialty chemical company focused on delivering sustainable solutions for mobility and wellbeing. They are seeking a Senior Manager for New Product Development in the Medical Devices sector, responsible for leading a team to manage the design and development of medical devices while ensuring 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

New Product DevelopmentFDA regulationsISO 13485Project ManagementMechanical EngineeringBiomedical EngineeringCatheter ManufacturingCAD toolsLeadershipCommunicationTeam CollaborationDetail-orientedStrategic Thinking

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

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

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

Preferred

Certification or formal training in ISO 13485 or FDA 21 CFR Part 820

Company

The Lubrizol Corporation

Glassdoor3.5

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.

Founded in 1928

Wickliffe, Ohio, USA

5001-10000 employees