Product Development Engineer

1 day ago

Durham, NC, United States Cynet Systems Full time
Job Description:

Requirement/Must Have:
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or equivalent.
  • Minimum of 2 years of experience in design and product development.
  • Proficiency with CAD tools (SolidWorks or similar) and engineering drawings.
  • Knowledge and execution of ISO 9001 quality systems.
  • Strong hands-on mechanical problem-solving skills.
  • Excellent documentation and communication skills.
Experience:
  • Product design and development across the full product lifecycle.
  • Rapid prototyping, design validation, and testing.
  • Component design and fabrication using machining, 3D printing, laser/die cutting, or thermoforming.
  • Root cause analysis and design failure mode analysis.
  • Working in regulated environments and design control systems.
Responsibilities:
  • Support product development projects for new models and design improvements focused on usability, realism, manufacturability, reliability, and cost.
  • Resolve design challenges through rapid prototyping, testing, and cross-functional collaboration.
  • Create and maintain design documentation including specifications, drawings, BOMs, test protocols, and reports.
  • Collaborate with suppliers, manufacturing, and quality teams to support scalable production and quality compliance.
  • Lead introductions of new and revised products to manufacturing.
  • Perform root cause investigations and support continuous design improvements.
  • Develop and document manufacturing process instructions for new and revised designs.
  • Sustain existing products to meet cost targets and maintain supply continuity.
  • Support product packaging testing and vendor coordination.
Should Have:
  • Experience working in FDA or ISO regulated environments.
  • Experience with packaging design and vendor management.
  • Familiarity with Agile or similar design control processes.
  • Exposure to lean manufacturing or continuous improvement methodologies.
Skills:
  • Mechanical design and prototyping.
  • SolidWorks and engineering documentation.
  • Fabrication methods and materials selection.
  • Design validation and testing.
  • Cross-functional collaboration.
  • Quality systems and documentation practices.
  • Organizational and multitasking abilities.
Qualification and Education:
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field.

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