At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 https://www.jnj.com
Job Function:
Supply Chain Engineering
Job Sub Function:
Manufacturing Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Alajuela, Costa Rica
Job Description:
Johnson & Johnson is hiring for a Manufacturing Engineer II to join our team located in Shockwave Medical Costa Rica.
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Position Overview
The Manufacturing Engineer II is responsible for providing engineering support to Production. Also responsible for designing, developing, testing, and implementing processes, tooling, and fixtures for commercial product. In addition, will sustain activities on the production line such as raw material, process and equipment issues.
Essential Job Functions
- Actively collaborate with Production to provide sustaining support in resolving product/process problems.
- Actively identify and participate in process/product, tooling, equipment, fixtures and cost reduction improvement projects.
- Coordinate and/ or perform functional and destructive testing of product for process validation or new supplier qualifications. Document the results and provide a statistical analysis using Minitab or excel.
- Participate as an extended team member for new product introduction.
- Participate in development and maintenance of process FMEAs, Manufacturing Process Instructions (MPIs), and Device Master Record (DMR) documents.
- Create and release label files used for printing product labels.
- Create and execute process validation protocols and reports.
- Create and maintain documentation for product configurations (e.g., bills-of-materials), and other Quality System requirements.
- Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.
Requirements
- Bachelor’s degree in engineering.
- 3-5 years of experience in a medical device environment.
- Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations.
- Understanding of Lean and Six Sigma concepts.
- Experience with Validation of Medical Devices (IQ-OQ-PQ).
- Basic understanding of Statistics (Cpk, Hypothesis Testing, DOE’s, Gage R&R) a plus.
- Able to create Solids and Drawings in SolidWorks.
- Ability to work in a fast-paced environment while managing multiple priorities.
- Operate as a team and/or independently while demonstrating flexibility to changing requirements.
- Employee may be required to lift objects up to 25lbs or more. Employees will be required to work in an air-conditioned office space.
