Johnson and Johnson
Location
Irvine, CA | United States
Job description
Biosense Webster Inc. , a member of the Johnson & Johnson Family of Companies, is recruiting for a NPD Assembler II.
*There is already a pre-identified candidate for this role. About Johnson & Johnson At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Job Description: The company is seeking NPD Assembler II who will work in a cleanroom environment to support the building and development of multiple catheter products. Follow a lean manufacturing process to achieve a daily build goal. Assist in building the next generation of catheter products . Key Responsibilities: • Assist engineers for failure analysis and troubleshooting • Complete, maintain, and verify documentation such as Device History Records per GDP and GMP requirements • Ensure Assemblers are following process instructions to build catheters to meet product development and launch commitments • Knowledgeable of the basic processes for catheter construction • Maintain clean and organized workstation • Maintain compliance with GMP, ISO, SOP, and safety guidelines • Manage daily line operations. Communicate with engineers and production managers to provide manufacturing updates. • Meet catheter manufacturing yield and productivity goals • Set up and work on the pilot line in the cleanroom to support the introduction of new products • Support activities related to prototyping, process validation, or equipment qualification • Train Assemblers on manufacturing processes and techniques. Develop and adhere to a training plan to ensure robust cross-training of the pilot line.Education: The applicants should have a High School Diploma or GED or equivalent experience Experience and Skills: Required: The candidates should have 4 years of experience as an operator or technician in small component or medical device manufacturing. Experience working in a regulated environment in compliance with ISO 13485 and 21 CFR 820. Preferred: • Ability to bring up issues, prioritize workload and manage time on a daily/weekly basis. • Ability to perform delicate assembly processes on small components or devices (examples include welding, swaging, soldering). • Ability to support troubleshooting and communicate information to engineers and production managers to assist with root cause analysis. • Demonstrated communication skills • Proficiency in basic digital literacy such as Microsoft Office (for email), Word, and Excel Other: • Be able to read and interpret work order instructions, SOP's, visual aids, and engineer drawings in English • This position is fully onsite in Irvine, California. • Frequently is required to stand, walk; use hands, handle or feel; and reach with hands and arms. • Regularly required to talk or hear. • Required to wear special garments and PPE when working in the cleanroom environment. • The employee will be using microscopes or close vision to perform his / her duties. Additional Information:Job tags
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