Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Senior R&D Engineer for Acclarent located in Irvine, CA The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Sedation and Reprocessing all headquartered in our talent hub in Irvine, CA.
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.
The Senior Engineer R&D will design, develop and commercialize next-generation medical devices used in the treatment of ENT diseases.
- Design and development of new devices or elements of new devices as assigned, with the intent of commercialization per Quality System Requirements.
- Document user and patient needs through design requirements, design specifications, and into verified/validated devices and procedures.
- Contribute to verification and validation activities through regulatory clearance and design transfer.
- Contribute in the generation of Intellectual Property and Interact with external (e.g. clinicians) and internal customers (e.g. strategic marketing) to identify user needs and validate device and procedure designs.
- Contribute in Technical and Peer Reviews.
- Contribute to development of design development plans and budgets.
- Proactively identify and act upon project risks and opportunities.
- Bachelor’s degree is required with at least 4 years of related engineering experience.
- A Bachelor’s or Master’s degree in mechanical, electrical or biomedical engineering is preferred.
- Experience in design, development and commercialization of Class I-II medical devices, specifically electro-mechanical, a disposable, minimally invasive, handheld surgical device is preferred.
- 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.
Acclarent, Inc. (6206)Job Function
R&D Engineering (R&D)