Talent.com
NPI Process Engineer II

NPI Process Engineer II

ATL TechnologyMaple Grove, MN, USA
30+ days ago
Job type
  • Full-time
  • Quick Apply
Job description

Essential Duties and 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

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.

    Job Posted by ApplicantPro

    Create a job alert for this search

    Npi Engineer • Maple Grove, MN, USA

    Related jobs
    • Promoted
    • New!
    Shopify QC Engineer

    Shopify QC Engineer

    VirtualVocationsSaint Paul, Minnesota, United States
    Full-time
    A company is looking for a Shopify QC Engineer to ensure high-performance digital experiences across their channels.Key Responsibilities Manage QA testing protocols for multiple Shopify stores, i...Show moreLast updated: 8 hours ago
    • Promoted
    Quality Engineer III (Manufacturing)

    Quality Engineer III (Manufacturing)

    Metal Craft | RiversideElk River, MN, United States
    Full-time
    The posted range reflects market-based pay.Actual compensation depends on experience, skills, and related qualifications. Applicants must be authorized to work for ANY employer in U.We are unable to...Show moreLast updated: 2 days ago
    • Promoted
    • New!
    Claims Production Analyst

    Claims Production Analyst

    VirtualVocationsSaint Paul, Minnesota, United States
    Full-time
    A company is looking for a Claims Production Analyst II.Key Responsibilities Research claims accuracy and execute necessary changes Perform data validation and audit claim files Assist in loadi...Show moreLast updated: 12 hours ago
    • Promoted
    • New!
    Process Engineer

    Process Engineer

    REQ SolutionsMaple Grove, MN, United States
    Full-time
    Job Title : Process Engineer - Medical Device.Duration : 12+ Months (Possible extension).Location : Maple Grove, MN 55311. Looking for someone with Biomed or ME engineering degree.Develops products, ma...Show moreLast updated: 1 hour ago
    • Promoted
    Quality Engineer

    Quality Engineer

    VelosityBrooklyn Park, MN, United States
    Permanent
    Quality Engineer to support our manufacturing facility in Brooklyn Park, MN.The Quality Engineer is responsible for supporting operations and project teams by providing statistical and technical su...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Quality Engineer

    Quality Engineer

    SciProEagan, MN, United States
    Temporary
    This is a 6 month contract with the possibility for extension or conversion.We are currently partnering with a client in the medical device industry to fill a Quality Engineer position.The ideal ca...Show moreLast updated: 1 hour ago
    • Promoted
    Process Engineering Consultant

    Process Engineering Consultant

    VirtualVocationsSaint Paul, Minnesota, United States
    Full-time
    A company is looking for a Process Manager for a 3-week contract.Key Responsibilities Conduct end-to-end process mapping of field service delivery workflows Perform gap analysis between acquired...Show moreLast updated: 1 day ago
    • Promoted
    Senior Mechanical Design Engineer

    Senior Mechanical Design Engineer

    VirtualVocationsSaint Paul, Minnesota, United States
    Full-time
    A company is looking for a Senior Mechanical Design Engineer to support the Molten Chloride Fast Reactor program.Key Responsibilities Coordinate input and requirements from engineering and projec...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    R&D Coordinator

    R&D Coordinator

    VirtualVocationsSaint Paul, Minnesota, United States
    Full-time
    A company is looking for an R&D Coordinator to support product development initiatives.Key Responsibilities Coordinate product development processes and improve project execution Procure materia...Show moreLast updated: 8 hours ago
    • Promoted
    Mechanical Design Engineer EIT

    Mechanical Design Engineer EIT

    VirtualVocationsSaint Paul, Minnesota, United States
    Full-time
    A company is looking for a Mechanical Design Engineer for a remote, contract opportunity.Key Responsibilities Develop material models and support novel analysis methodologies in the Mechanical De...Show moreLast updated: 1 day ago
    • Promoted
    Design Engineer - Municipal

    Design Engineer - Municipal

    Bolton & Menk, Inc.Chaska, MN, United States
    Full-time
    Bolton & Menk has an exciting opportunity for a Design Engineer, EIT, to join our Municipal team in our Chaska office.As a Top Workplace, this is a fantastic chance to work with a talented team of ...Show moreLast updated: 30+ days ago
    • Promoted
    DESIGN ENGINEER

    DESIGN ENGINEER

    VelosityForest Lake, MN, United States
    Permanent
    Design Engineer on 1st shift to support our manufacturing facility in Forest Lake, MN.This position will report to the Director of Operations, and has no direct reports. The typical pay range for th...Show moreLast updated: 30+ days ago
    • Promoted
    Manufacturing Engineering Co-Op - Spring 2026

    Manufacturing Engineering Co-Op - Spring 2026

    EntegrisChaska, MN, United States
    Full-time
    Manufacturing Engineering Co-Op - Spring 2026.Manufacturing Engineering Co-Op - Spring 2026 Here at Entegris, we use advanced science to enable technologies that transform the world, and we are see...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Engineer II

    Quality Engineer II

    BTD ManufacturingLakeville, MN, United States
    Full-time
    BTD is a fast growing metalworking company.We provide custom metalwork services for some of the world's top brands.Our 1400+ employees work from four facilities throughout the Midwest and Southeast...Show moreLast updated: 30+ days ago
    • Promoted
    Generative AI Product Engineer

    Generative AI Product Engineer

    VirtualVocationsSaint Paul, Minnesota, United States
    Full-time
    A company is looking for a GenAI Product Engineer to design, build, and evaluate Generative AI solutions across cloud environments. Key Responsibilities Design and develop solution architectures f...Show moreLast updated: 1 day ago
    • Promoted
    Senior NPD Quality Engineer

    Senior NPD Quality Engineer

    Trelleborg Medical SolutionsDelano, MN, United States
    Full-time
    Trelleborg Medical Solutions partners with the world’s leading medical device and biopharmaceutical companies, collaborating from concept to commercialization to bring to market impactful solutions...Show moreLast updated: 11 days ago
    • Promoted
    Sr Quality Engineer

    Sr Quality Engineer

    Cypress HCMNew Hope, MN, US
    Full-time
    A medical manufacturing client in New Hope, Minnesota is looking to hire a senior quality engineer to join their team.This Sr Quality Engineer is primarily responsible for providing technical suppo...Show moreLast updated: 12 days ago
    • Promoted
    Industrial Engineer

    Industrial Engineer

    Egan CompanyChamplin, MN, United States
    Part-time
    Are you a natural systems thinker with a passion for efficiency? Egan Company is seeking an.Electrical Solutions & Prefabrication team in Champlin, MN. A strong candidate in this role is someone who...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Design Engineer - Transportation

    Design Engineer - Transportation

    Bolton & Menk, Inc.Burnsville, MN, United States
    Full-time
    Bolton & Menk has an exciting opportunity for a Design Engineer, EIT, to join our Transportation team in our Oakdale office. As a Top Workplace, this is a fantastic chance to work with a talented te...Show moreLast updated: 7 hours ago
    • Promoted
    Process Engineer

    Process Engineer

    Genuine Search GroupSaint Paul, MN, US
    Full-time
    The role involves using scientific methods to develop the molding process for each mold while interacting heavily with tooling and production personnel. This position offers succession and career pr...Show moreLast updated: 4 days ago