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Senior Engineer, NPI/Lifecycle Management

Company: Johnson & Johnson
Location: Irvine
Posted on: July 15, 2019

Job Description:

Johnson & Johnson's Family of Companies is recruiting for an Engineer, Product Management NPI/LCM to be located in Irvine, CA to support our Acclarent business.Chronic sinusitis affects 3 million Americans each year and five per cent of the U.S. adult population suffers from a phenomenon referred to as Eustachian Tube Dysfunction (blocked ears / ear pain). Acclarent, Inc. is dedicated to supporting otolaryngologists with minimally-invasive ENT technologies that relieve this suffering as effectively and painlessly as possible. For more than a decade Acclarent, Inc. has pioneered innovative technologies, including the balloon dilation system that's been used to treat more than one million patients.The Engineer performs a wide variety of technical tasks and projects in the development of new products and manufacturing processes. You will be a key member of Acclarent's medical device product development teams.Duties & Responsibilities Accurately and efficiently translates designs into documented processes and procedures Designs, develops and refines processes, including scoping and challenge testing of outputs Participates in the creation and execution of engineering build packages Maintains a lab notebook compliant with Acclarent's procedures Qualifies equipment and fixtures Serves as a technical interface within Acclarent between the manufacturing and Materials, R&D, quality, regulatory and marketing organizations Manages and designs/develops new products and processes as well as product changes and improvements Plans, schedules and completes projects in a timely manner Writes test protocols and reports for design verification/process validation, completes testing and transfers products to manufacturing Finishes required production documentation, including Manufacturing Process Instructions (MPIs), Lot History Records (LHRs) and Bills of Material (BOMs) Lead cost reduction, labeling, process improvement, and other Lifecycle Management projects Directs technicians' activities, as needed Other responsibilities as required or assigned by the managerQualifications Bachelor's degree in mechanical engineering or related discipline is required Minimum of 2 years of experience in a directly related experience is required Ability to manage time and other resources effectively (or project management) Knowledge of and compliance with applicable Quality System requirements (e.g., QSRs, ISO & MDD) preferred Strong written and verbal communication skills to communicate effectively to individuals and groups at all levels Proficient with Microsoft Word, Excel and Project Experience with SolidWorks or other related applications Experience with MiniTab is preferred Basic application/knowledge of medical device regulatory requirements and standards highly preferred Experience in medical device manufacturing preferred or highly regulated industry Proven application of statistical techniques Position location: Irvine, CA and will require travel up to 20%Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.Primary LocationUnited States-California-Irvine-OrganizationAcclarent, Inc. (6206)Job FunctionProcess EngineeringRequisition ID

Keywords: Johnson & Johnson, Irvine , Senior Engineer, NPI/Lifecycle Management, Executive , Irvine, California

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