Principal Engineer, New Product Introduction (R&D Manufacturing) Job

Job description

Principal Engineer, New Product Introduction (R&D Manufacturing)-6678150821DescriptionAcclarent, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Principal Engineer, New Product Introduction to be located in Irvine, California.
Acclarent, Inc. is a medical device company that was 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.Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Principal Engineer, New Product Introduction manages a wide variety of technical tasks and projects in the development of new products and manufacturing processes. This individual will be a leader within the New Product Introduction group and a key member of Acclarent’s medical device product development teams.
The Principal Engineer will contribute directly to the development of new product concepts, processes, and techniques to ensure that products meet customer’s needs and are high quality and low cost product. This individual will serve as a technical interface within Acclarent between the Manufacturing and Materials, R&D, Quality, Regulatory, and Marketing organizations. S/he will manage/hands-on design and development of new products and processes as well as product changes and enhancements. S/he will demonstrate knowledge to molded and machine part design as it relates to manufacturability. S/he will work closely with external partners to transfer new mechanical products to manufacturing. This person will plan, schedule and complete projects in an aggressive manner. S/he will possess a working application/knowledge of medical device regulatory requirements and standards. This individual will write test protocols and reports for design verification/process validation, complete testing, and transfer to manufacturing. Including Manufacturing Process Instruction (MPI), Lot History Record (LHR), Bill of Material (BOM) and other production documentation. S/he will lead and directly participate in the design and testing of manufacturing fixtures and equipment. S/he will contribute in generation of intellectual property and assist in management of Acclarent’s IP. S/he directs activities of technicians and/or other engineers as needed. This person will maintain a lab notebook compliant with the company’s procedures. Other responsibilities as required or assigned by manager.
J2W: LI NAQualificationsThe ideal candidate will have a minimum of a Bachelor’s degree in Engineering, with a minimum of 8 years of demonstrated leadership in a directly related field is required. The ability to manage resources: time, budget, and people are required. This person must have the ability to work cross-functionally with teams is required. Prior experience in medical device manufacturing is preferred. Proven application of statistical techniques, Design of Experiment (DOE), and Design for Manufacturing (DFM) experience is preferred. Knowledge of and compliance with applicable Quality System requirements (e.g., QSRs, ISO & MDD) and experience working in a regulated environment is preferred. Experience with injection molding and extrusions is strongly preferred. Strong written and verbal communication skills to communicate effectively at all levels is required. Good presentation skills to deliver speeches and/or presentations effectively to a variety of audiences is required. Proficiency with MS Word, Excel and Project is required. Experience with CAD, preferably SolidWorks are preferred. This position is based in Irvine, CA and may require up to 20% travel Domestic and International.
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Primary Location:North America-United States-California-IrvineOrganization: Acclarent, Inc. (6206)Job Function: Engineering (Generalist)Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and 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. EEO is the Law EEO is the Law GINA Supplement