ATL Technology · 4 hours ago
NPI Process Engineer II
Maple Grove, MN
Full-time
Hybrid
Entry, Mid Level
2+ years expATL Technology is committed to improving the quality of life through custom engineered solutions for medical devices. The NPI Process Engineer II will plan and direct validation activities, maintain documentation, and support engineering teams in product development and manufacturing processes.
ElectronicsManufacturing
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 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
Qualification
Required
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
Ability to utilize business process understanding and change management procedure to resolve complex and systemic organizational problems
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
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
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
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
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
Preferred
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
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
Company
ATL Technology
ATL Technology is an electronic manufacturing company offering electromechanical manufacturing services.
1001-5000 employees
H1B Sponsorship
ATL Technology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2020-01-01Private Equity
Leadership Team
David Smith
Chief Operating Officer
Recent News
Google Patent
2025-05-05
Medical Product Outsourcing
2025-03-21
2025-02-22
Company data provided by crunchbase