Johnson & Johnson Careers
Staff Engineer, NPI and Life Cycle Engineering
Requisition ID: 0118180626
Acclarent is recruiting for a Staff Engineer, NPI and Life Cycle Engineering, located in Irvine, CA.
Acclarent, Inc. is a medical device company, established in June of 2004. The company is dedicated to the development of innovative devices providing new technologies to further meet the needs of ENT patients. Acclarent's initial focus is on achieving the goals of sinus surgery with novel, endoscopic, catheter-based tools - Balloon Sinuplasty™ devices. Through the Balloon Sinuplasty™ technology and our Relieva® product portfolio we offer ENT patients another option to conventional endoscopic surgical technologies. FDA clearances for these devices were completed in 2005 and the products were commercially launched in the US that same year. Through our core technologies and commitment to innovation, Acclarent will continue to advance novel devices in all areas of ENT.
As a Staff Engineer you will manage a wide variety of supply chain related tasks and projects in the support of new product development and commercialized medical devices. In this role, you will be a key contributor within the Product Management group and Acclarent’s medical device product development teams.
• Contributes directly to the development of new processes and techniques to ensure that products are high quality, low cost and meet customers’ needs
• Leads and executes engineering projects in support of commercialized projects. Includes costs savings, design changes, labeling, and others.
• Serves as a technical interface at Acclarent between the supply chain, R&D, quality, regulatory and marketing organizations
• Leads design for manufacturability and design for assembly activities
• Participates in the creation and execution of engineering build packages
• Maintains a lab notebook, compliant with Acclarent’s procedures
• Assists in the design of equipment and fixtures
• Plans, schedules and completes projects in an aggressive manner
• Writes test protocols and reports for design verification/process validation, and transfers to manufacturing
• Other responsibilities as required or assigned by manager
• Bachelor’s degree in mechanical engineering or related discipline required
• At least 6 years of related professional experience required
• Ability to manage budget and time resources required
• Knowledge of and compliance with applicable Quality System requirements (e.g., QSRs, ISO & MDD) is preferred
• Strong written and verbal communication skills to communicate effectively with individuals and groups at all levels required
• Presentation skills to deliver speeches and/or presentations effectively to a variety of audiences required
• Proficient with Microsoft Word, Excel and Project required
• Working application/knowledge of medical device regulatory requirements and standards preferred
• Experience working in a highly regulated industry required
• Experience in medical device manufacturing is preferred
• Proven application of statistical techniques and Design of Experiment (DOE) preferred
• Proficiency in Solid Works preferred
• Ability to travel up to 15% domestic and international required
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Acclarent, Inc. (6206)