NPI Process Engineer II

ATL Technology • Osseo, MN, US

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Responsibilities

Plans, executes, and directs validation activities for both NPI and existing product lines, including but not limited to : VMP, IQ, OQ, PQ, PPQ, etc.
Maintains and creates documentation including validation protocols, SOPs, test plans, test reports, PFMEA, VMP, quality and validation reports, technical proposals, and more.
Performs root cause analysis (RCA) and resolves design or manufacturing issues.
Supports Engineering teams on reviewing, designing, prototyping, and testing.
Supports and coordinates with internal and external Engineering teams to create solutions, meet deadlines, and provide customer satisfaction throughout the product life cycle.
Guides and works with other engineers (domestic and international).
Manages engineering projects of varying size and complexity.
Occasional travel is required.
Performs other duties and responsibilities as assigned.

Qualifications

Bachelor\'s Degree in Mechanical or Manufacturing Engineering, or similar technical program.

Minimum 2+ years of experience on catheter manufacturing process development, or equivalent combination of education and experience.

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.

Background in design for manufacture, quality processes, and documentation of highly regulated (medical or similar) products is a plus.

Experience supporting domestic and off-shore manufacturing is a plus.

Experience conducting / documenting design reviews, root cause analysis, troubleshooting, and technical risk analysis activities.

Ability to obtain a passport / visa and travel domestically and internationally as required.

College-level verbal and written communication skills with both technical and non-technical audiences.

Experience with design / production of medical devices under ISO 13485.

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.

Continuous improvement mindset and commitment to process development.

Ability to problem solve decisively and independently while demonstrating appropriate judgment on communication and escalations.

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.

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Npi Engineer • Osseo, MN, US