Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Manager, R&D for Acclarent to be 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 (ENT).
The Manager will lead, oversee and manage the design, development and commercialization of next-generation innovative medical devices used in the treatment of ENT diseases.
- Responsible for 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.
- Set clear expectations for direct reports and the cross-functional team, establish roles and responsibilities to manage deliverables to meet business commitments.
- Effectively communicate with Business leaders, Executive Management and key stakeholders on a regular basis to ensure alignment on project baseline (scope, schedule, and budget), report on execution of project deliverables and mitigation of risks.
- 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 will 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.
- A Master's degree is required
- PhD in an Engineering discipline preferred
- PhD in Mechanical Engineering preferred
- A minimum of 10 years of relevant engineering experience required
- Experience in the design and development of surgical navigation and surgical tools is preferred
- Experience engaging with physician customers and/or Scientific Advisory Board (SAB) members to discuss and evaluate design concepts to drive innovation 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 required
- Previous supervisory experience preferred
- The position will be based in Irvine, CA and will require frequent travel.
Acclarent, Inc. (6206)Job Function