Manufacturing Project Engineer III - NP Medical/Nypro Healthcare

About Our Company

NP Medical Inc., a subsidiary of Nypro, a Jabil company, is an innovator and supplier of medical devices that address the large-scale needs of the infusion therapy and vascular access markets. The goal that motivates us every day is to provide compelling product solutions that make quality patient care possible by improving patient outcomes and caregiver safety at an affordable cost. It is a deep understanding of the consequence of our work that has fueled NP Medical's product innovation, guided our daily operations, and defined our customer and caregiver engagement for over thirty years. This rich tradition has produced an enduring and winning culture marked by excellence, compassion, and collaboration that extends to our customers, caregivers, and patients alike.

Job Summary

The project engineer will facilitate and lead the strategic automation initiatives for assigned medical device projects. The project engineer will have responsibility for overall automation project compliance to NP Medical's established procedures for equipment URS, equipment validation, process development and validations, and transfer to production. Using established processes and procedures, the Project Engineer is responsible for overseeing outside automation vendors in the design, fabrication, and qualification of automated assembly solutions for class 2 single-use, disposable medical device products. Manage and enhance supplier relationships by providing single-point-of-contact to automation and robotics solution suppliers for all project-related activities and ongoing Production Life Cycle Management. The project engineer will be responsible for project budget, schedules, and establishment and delivery of all valid requirements to meet the project objectives. Direct and guide the Engineering team members (including technicians) in the area of responsibility with a high level of integrity, efficiency, and enthusiasm, striving to achieve excellence in all endeavors. Represent the engineering function of technical support, in conjunction with other internal support groups, regarding opportunities for improvement affecting manufacturing and accomplishing the Jabil 'Quality Policy'

Essential Duties & Responsibilities

  • Develops and implements the manufacturing process to achieve efficiency, quality, and/or cost improvements for existing product lines and also by participating in new product development programs
  • Develops requirement specifications, system concepts, CAD generated machine layouts, detail drawings, BOM's and budgets. Makes layouts of complex assemblies and details of parts of devices, mechanisms and structures.
  • Works with manufacturing to trouble-shoot problems, upgrades, retrofits, set-ups, methods development, and the development of process parameters
  • Participates in product development meetings and may make recommendations to product design changes to enhance manufacturing and assembly
  • Identification and Supplier Evaluation of Automation and Robotics Vendors
  • Collaborate with vendors to develop plans for automation deployment, process development and validation that support business objectives and oversee the effective execution of these plans
  • Aligns project team(s) to program requirements through establishment of a regular communications, including an updated project schedule, containing milestones, goals, and objectives based on input from applicable functional areas and stakeholders.
  • Collaborates with internal and external manufacturing base to assure that designs are suitable for manufacture (DFX) and that process risks are considered and mitigated as far as possible within design.
  • Manages development of project plans with a focus on achievement of project goals and corporate initiatives, including project specific Key Performance Indicators (KPI's) or metrics.
  • Coordinates and/or participate in risk assessments associated with automation design, assembly process development, robotics and application
  • Interface with Quality, Design, and Manufacturing Engineers to review processes, determine validation requirements, and coordinate the validation
  • Write validation protocols and reports as required
  • Utilize advanced statistical tools to determine sampling plans and to analyze data associated with validation activities
  • Direct vendors in the execution of process validations, gage R&Rs;, IQs, OQs, and PQs as required
  • Coordinate and/or perform testing relating to the automated assembly process validations
  • Works with suppliers and internal NP Medical stakeholders in the resolution of quality problems associated with automated assembly processes and its validations
  • Conduct proof of concept experiments and design other testing requirements as needed
  • Research new technology or development tools to remain informed of current technology

Education & Experience Requirements

  • Bachelor's Degree in Engineering OR equivalent education and training.
  • 4-6 Years of related Engineering experience, 2-4 with Masters Degree
  • Experience in Class 2 medical device development, cGMP validation engineering, or sustaining engineering or equivalent

Knowledge Requirements

  • Experience working within a 21 CFR 820 and/or ISO 13485 compliant quality system
  • Experience with low and high volume automated assembly operation
  • Previous manufacturing process development experience
  • Strong leadership skills plus attention to details to drive projects to completion on time through active interaction with suppliers and core team members
  • Strong organizational and planning skills
  • Strong interpersonal verbal communication skills and strong written communication in status updates, specifications, protocols and reports
  • PC application skills: MS Project, Excel, Word, PowerPoint, and Mini-tab (or equivalent statistical software)
  • Ability to effectively present information and respond to questions from groups of managers, customers, internal team members and suppliers.
  • Knowledge of conventional drafting standards (ASME Y14.5) and ability to interpret GD&T;
  • Previous experience using an enterprise PLM system (Windchill, Agile, etc) and/or a MCAD package (Solidworks preferred) is a plus
  • Six Sigma certification is a strong plus

Jabil is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other status protected by law.

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