MANUFACTURING ENGINEER II - SHOCKWAVE MEDICAL

Johnson & Johnson is recruiting for Manufacturing Engineer II for Shockwave Medical Inc.
located in Alajuela, Costa Rica.
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.
nj.
om/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.
Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve.
Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
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, the Manufacturing Engineer II 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.
.,  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.
Qualifications 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).
Intermediate 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.