Cardiovascular Specialty Solutions Group (CSS) Group is a Family of Companies within Johnson & Johnson, is recruiting for a Principal Engineer, R&D located in Irvine, CA. This position will require frequent travel on regular basis to Menlo Park, CA for duration of 2015.
Cardiovascular Specialty Solutions Group (CSS) Group is combining ASP, Acclarent, Biosense Webster and Mentor into a single business unit, single global management board, single P&L.
One geographic Medical Device hub in Irvine will allow for critical mass and geographic efficiencies, including an enhanced ability to attract and develop talent and drive product portfolio to accelerate innovation.
Acclarent, Inc. is a medical device company, whose singular focus is to free patients to live better lives by designing, developing, and commercializing medical devices that address conditions affecting the ear, nose, and throat (ENT).
Advanced Sterilization Products (ASP) truly makes a difference by Protecting Lives against Infection®. ASP has been innovating since 1987 to help healthcare facilities protect patients with best-in-class infection prevention solutions.
Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders and one of the fastest-growing businesses within Johnson & Johnson.
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 and non-surgical medical procedures that allow patients to improve their quality of life through breast, body and facial aesthetics.
The Principal Engineer will Lead the design, development and commercialization of next-generation medical devices used in the treatment of ENT diseases. Lead conceptualization, design and development of new devices or elements of new devices with the intent of commercialization per Quality System Requirements . 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. Lead in the generation of Intellectual Property.
The Principal Engineer will Drive Collaboration with external (e.g. clinicians) and internal customers (e.g. strategic marketing) to identify user needs and validate device and procedure designs. Serve as an expert in Technical and Peer Reviews and May involve direct or indirect supervision of engineers and/or technicians. Serve as a strong mentor to other technical contributors. Lead the development of design development plans and budgets and coach teams to execute aggressively and predictably. Proactively identify and act upon project risks and opportunities.
Bachelor’s degree is required and at least 10 years of related experience is preferred Three years’ experience in the design and development of surgical navigation and surgical tools is required. Experience engaging with physician customers and/or Scientific Advisory Board (SAB) members to discuss and evaluate design concepts to drive innovation is required. A Master’s degree or PhD in engineering field is preferred . Experience in design, development and commercialization of Class I-II-III medical devices, specifically electro-mechanical, a disposable, minimally invasive, handheld surgical device is preferred. Experience designing with 3D CAD tools (e.g., SolidWorks, rapid prototyping), including hands-on manual prototyping, SLA and FDM is preferred. The ability to move materials and light equipment (up to 10 pounds) is required. The position will be based in Irvine, CA and will require frequent travel on regular basis to Menlo Park, CA for duration of 2015.
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