NPI Process Engineer II

Essential Duties and Responsibilities:

Obligaciones y responsabilidades esenciales:

• 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 RCA (Root Cause Analysis) 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
• Guiding and working with other Engineers (Domestic and International)

• Manage Engineering projects of varying size and complexity.

• Occasional traveling is required

• Performs other duties and responsibilities as assigned

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Language Skills:

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Business Process Skills: Ability to utilize business process understanding and change management procedure to resolve complex and systemic organizational problems.

Mathematical Skills:

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Physical Demands:

The physical demands described here are representatives of those that must be met by an employee to successfully perform the essential functions of this job.

• Is occasionally required to stand; walk; reach with hands and arms; and lift up to 25 pounds.
• Is frequently required to sit; use hands to finger, handle, or feel; and talk or hear.
• Has the ability to adjust the eye to bring an object into sharp focus.
• Works in moderate noise levels

Education & Experience Requirements:

• 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 judgement 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.