Mentor Worldwide LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Engineer, R&D located in Irving, Texas.

Mentor Worldwide LLC is a leading supplier of medical products for the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical medical procedures that allow patients to improve their quality of life through breast, body and facial aesthetics. Learn more about Mentor at www.mentorwwllc.com

The Senior Engineer, R&D will have the responsibility of leading and contributing to various cross-functional multidisciplinary project teams, such as R&D, manufacturing, marketing, and regulatory and will work on designing, developing and manufacturing of Mentor products - Breast Implants, Tissue Expanders, and other related products.

• Lead conceptualization, design and development of new devices or elements of new devices with the intent of commercialization per Quality System Requirements
• Contribute to design/development of product line extensions and product improvements
• Help lead design, development, execution and analysis of results of system, device, component and material tests per laboratory best practices
• Accurately and efficiently translate user and patient needs through design requirements, design specifications and into verified/validated devices and procedures
• Lead verification and validation activities through regulatory clearance and design transfer
• Contribute strongly in the generation of intellectual property
• Collaborate with external (e.g., clinicians) and internal customers (e.g., strategic marketing) to identify user needs and validate device and procedure designs
• Collaborate with clinical, regulatory, quality, manufacturing, etc., to ensure development of innovative and reliable devices that fulfill clinical needs within regulatory requirements
• Help manage development partners and other external vendors to meet project requirements and timelines
• Coordinate and execute technical and peer reviews; may also include coordination and execution of design reviews
• May involve direct or indirect supervision of engineers and/or technicians
• Other responsibilities as required or assigned by manager

• Bachelor's degree in mechanical or chemical engineering, or equivalent
• At least 4 years related experience
• Experience in New Product Development
• At least 3-5 years of experience in the Medical Device industry
• Strong knowledge of Design Control principles

• 5-10 years of experience in design, development and commercialization of Class I-III medical devices, specifically electro-mechanical, disposable, minimally invasive, handheld surgical devices
• Designing with 3D CAD tools, including SolidWorks and rapid prototyping, including hands-on manual prototyping, SLA and FDM

• Location - Irving TX / Raritan NJ
• Travel - Less than 10% travel required
• Office and lab environment
• Ability to move materials and light equipment (up to 10 pounds) as needed