Senior Engineer, R&D

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.

Responsibilities/Duties


* 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

Qualifications:

Required:


* 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

Preferred:


* 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...