15 May

Project Development Engineer Jobs Vacancy in Robling Medical Inc Youngsville

Position
Project Development Engineer
Company
Robling Medical Inc
Location
Youngsville NC
Opening
15 May, 2018 7 days ago

Robling Medical Inc Youngsville urgently required following position for Project Development Engineer. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

Project Development Engineer Jobs Vacancy in Robling Medical Inc Youngsville Jobs Details:

General Summary

The Project Development Engineer is responsible for supporting project teams in the development & validation of robust processes, assembly tools & methods, manufacturing processes, etc. This position requires 1) technical expertise in research, design, development, validation, & implementation activities for associated materials, components, assemblies, processes, tooling/fixtures, & equipment required to complete projects; 2) communicating with customers, vendors, project teams, & assists project managers with coordination of team activities; 3) report preparation for project status & validation activities; 4) assisting the Engineering (NPI) team with the development cost-effective & efficient processes; 5) participation on a team that ensures robust processes are ready for transfer to the Robling Medical manufacturing environment on time.

Primary Duties & Responsibilities

  • Prepares & executes validation protocols, engineering studies, DOEs, & subsequent reports
  • Assists with the development & maintenance of pFMEAs
  • Assists with the development & maintenance of graphic design files (regulatory label files, etc.)
  • Assists with design & maintenance of 3D models & engineering drawings for components & assemblies for product, tooling, & fixturing
  • Participates in cross-functional teams in the coordination of projects & all project elements required to meet all deadlines
  • Assists with project & technical leadership to customers, vendors, & in-house project teams in bringing a product design to market
  • Reviews, monitors, & reports on project progress to ensure adherence to requirements of contract, FDA, & ISO requirements
  • Communicates in verbal & written form on a regular basis with customers, vendors, & in-house project teams
  • Effectively engages in customer interactions to ensure success for existing projects; presents & explains project documents, reports, & findings to customers
  • Provides hands-on technical leadership through the development engineering cycle & recommends design, method, workflow, etc. solutions as required
  • Assists with the creation & review of product design & material specifications, assembly processes, tooling & fixture designs, & packaging designs for compliance with engineering principles, company standards, customer contract requirement, & related specifications
  • Capable of providing guidance & recommendations for the proper statistical models needed in order to justify V&V activities to meet regulatory requirements
  • Participates in special projects as required

Required Qualifications

  • 4-year degree in an Engineering field (Biomedical, Mechanical, Industrial or Electrical) or equivalent combination of 4-year degree & applicable experience with at least 2 years of experience in the field. Applicable internship experience may also be considered.
  • DOE execution
  • Validation protocol, execution, & report writing
  • Experience in developing & maintaining pFMEAs
  • Strong project management skills
  • Excellent interpersonal skills & written communication
  • Strong analytical skills & attention to detail
  • Highly motivated self-starter with ability to drive for results
  • Demonstrated ability to effectively organize, prioritize & accomplish multiple tasks; makes decisions & solves problems independently
  • Experience in a fast-paced environment where ‘speed to market” is identified as a key performance indicator
  • Strong computer skills (MS Word, Excel, PowerPoint, Outlook, Project Management Tools, CAD, Statistical Software, Graphic Design Tools)

Preferred Qualifications

  • Experience in an ISO900x or ISO13485 manufacturing environment
  • Medical Device or Pharmaceutical development or manufacturing experience
  • Experience with sterile packaging & terminal sterilization processes such as EtO, Gamma, etc.
  • Technical skills in manufacturing processes & methods including flow, layout, assembly & production equipment
  • Cross-discipline engineering experience
  • Demonstrated ability to lead & manage a team
  • Experience in troubleshooting & repairing equipment
  • Experience with heat sealing, vacuum forming, RF welding, high speed packaging lines, adhesive dispensing systems, cutting/punching/skiving/forming thermoplastics, inspection & test equipment (leak testing, scales, force gauges, etc.)
  • Lean Six Sigma Green Belt Certification
  • Experience with MiniTab
  • Experience with SolidWorks
  • Experience with electro-mechanical devices & equipment (design, fabrication/assembly, installation, qualification, operation)

Environment & Working Conditions

  • Sitting &/or standing for long periods of time
  • Visual - constant visual attention; color vision, depth perception & ability to adjust focus
  • Bending; also reaching with hands & arms
  • May occasionally lift &/or move up to 50 pounds

Job Type: Full-time

Experience:

  • Project Management: 2 years
  • Manufacturing: 2 years
  • Medical Device: 2 years

Education:

  • Bachelor's

Required work authorization:

  • United States


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