NPI Process Engineer II
The NPI Process Engineer II will work directly with Engineering and Manufacturing managing various projects geared toward designing efficiency, cost effectiveness and safety controls within our manufacturing and engineering processes.
What you will be doing:
The NPI Process Engineer II will plan, execute, and direct validation activities for both NPI and existing product lines as well as maintain and create documentation including validation protocols, SOPs, test plans, test reports, PFMEA, VMP, quality and validation reports, technical proposals and more.
They will perform RCA (Root Cause Analysis) and resolve design or manufacturing issues as well as support Engineering teams on reviewing, designing, prototyping, and testing. In addition, they will support and coordinate with internal and external Engineering teams to create solutions, meet deadlines, and provide customer satisfaction throughout the product life cycle
The NPI Process Engineer II will work with other engineers on managing engineering projects of varying size and complexity. Occasional traveling is required.
What we expect from you:
Our ideal candidate will have a bachelor's degree in Engineering or similar technical programs and have a minimum of 2+ years experience with catheter manufacturing process development. This candidate will have an understanding of product validation, manufacturing processes, and development of electrical and mechanical devices; performance of new technology research; creation of product documentation, product testing protocols, and test reporting. They need to have a background in design for manufacture, quality processes, and documentation of highly regulated (medical or similar) products.
The ideal candidate will have an understanding of manufacturing methods related to catheter fabrication and experience working with extrusion, braiding, lamination, and secondary operations. Strong writing skills creating documentation as mandated by ISO 13485, FDA, or similar regulations where knowledge of the regulation or standard is required. They need to have experience with design/production of medical devices under ISO 13485.
What's in it for you:
What you should know about us:
We believe there is a better way to bring medical devices to market. We use an engineer-to-engineer approach to develop custom interconnect solutions for medical devices that improve the quality of one's life'. Join us in our mission to be the leading provider of custom engineered solutions for top medical device manufacturers. ATL has operations in China, Costa Rica, Taiwan, UT-USA, plus remote staff in strategic global locations ... and we're growing!
Our Values:
Honesty
Excellence
Accountability
Respect
Teamwork
EEO Statement
ATL Technology provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
