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Project Development Engineer
Ref No.: 18-33592
Location: Youngsville, North Carolina
Position Type:Direct Placement
Experience Level: 5 Years
Pay Rate : $ 60,000.00 - 80,000.00 /Year
Shift:First
Job Category:Engineering
Benefits:401K, Dental Insurance, Life Insurance, Medical Insurance, None, Vision Insurance
Project Development Engineer – Wake Forest/Youngsville, NC

On-Board PMO is hiring for a Project Development Engineer in the Wake Forest/Youngsville, NC area. You will be 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 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
  • 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
  • A minimum of 5 years of experience in the medical device field
  • 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
  • Experience with device 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)


On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.