Website Johnson & Johnson
NPD Engineer I Job Highlights
|Title||NPD Engineer I|
|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 is a part of the Johnson & Johnson family of companies. It is a global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter.
The company is looking for an NPD Engineer I who will perform and detail moderately sophisticated technical and operational functions relating to the building and development of multiple catheter products.
Follow a lean manufacturing process to achieve daily operations goals. Assist in building the next generation catheter products in the New Product Development Pilot Line cleanroom requiring operational judgment.
- The applicants should have passed an Engineering Degree (program) in any specialty from a college/university.
- The candidates should have experience working in a regulated environment in compliance with ISO 13485 and 21 CFR 820.
- Complete, maintain and verify documentation such as Device History Records per GDP and GMP requirements
- Conduct failure analysis and troubleshooting
- Knowledgeable of the basic processes for catheter construction.
- Maintain a clean and organized work area.
- Maintain compliance with GMP, ISO, SOP, and safety guidelines
- Manage daily line operations. Connect with engineers and production managers to provide manufacturing updates.
- Meet catheter manufacturing yield and productivity goals, to meet product development launch commitments.
- Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures
- Responsible for providing guidance and direction to leads and other line team members on meeting operational, Compliance, Health/Safety, and Environmental practices.
- 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.
- Performs other duties assigned as needed
- The ability to escalate issues, prioritize workload and manage time on a daily/weekly basis is required.
- Demonstrated oral and written communication skills.
- Knowledge of good manufacturing practices and documentation, preferably in the medical industry.
- Preferably knowledge in the medical industry.
- Preferred working knowledge of assembly processes on small components or devices (examples include welding, swaging, soldering, etc.)
- Proficiency in computer skills such as Microsoft Office, statistical tools, and other computer programs.
- The ability to support troubleshooting, analysis, and communication information to other engineers and management is required.
Work Environment/Physical Demands
- Employees are required to wear special garments and PPE when working in the cleanroom environment.
- The employee frequently is required to stand, walk; use hands, handle or feel; and reach with hands and arms.
- The employee will be using microscopes or close vision to perform his/her duties.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- This position may require up to 10% domestic travel or international travel.
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.