Website Johnson & Johnson
NPD Pilot Line Assembler III Job Highlights
|Title||NPD Pilot Line Assembler III|
|Location||Irvine, CA, United States|
|Company||Johnson & Johnson|
Johnson & Johnson is the largest and most broadly-based healthcare company in the world. We’re producing life-changing breakthroughs every day.
Biosense Webster a part of the Johnson & Johnson family of companies, is the global leader in the science of diagnosing and treating heart rhythm disorders.
The company is seeking NPD Pilot Line Assembler III 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.
- The applicants should have a High School Diploma or GED
- 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.
- 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 matrix to ensure robust cross-training of the pilot line.
- Ability to escalate 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 computer skills such as Microsoft Office (for email), Word, and Excel
Work Environment/Physical Demands
- 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.
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.
To apply for this job please visit jobs.jnj.com.