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Packaging Engineering Specialist

2 months ago

San Diego, California, United States Cynet Systems Full time
Job Overview:

Compensation: Pay Range $43.98/hr - $48.98/hr

Position Summary:
As a key player in the Research and Development Packaging Engineering team, you will oversee the development and lifecycle management of innovative products within the medical device sector. Your expertise will guide the design control processes and ensure adherence to superior engineering and documentation standards.

Key Responsibilities:
  • Lead the R&D deliverables through the medical device design control process, focusing on intravenous infusion sets and connection devices.
  • Collaborate effectively within a cross-functional team to plan, develop, modify, implement, and support products utilizing rigorous engineering methodologies.
  • Engineer durable products by applying a strong understanding of engineering principles and utilizing Design for Six Sigma (DFSS) methodologies and tools such as Kaizen for process enhancement.
  • Formulate technical plans and guide the team in developing design inputs, conducting feasibility studies, refining product designs, and ensuring comprehensive documentation for global regulatory compliance.
  • Conduct design verification testing to validate that design outputs align with established input requirements.

Qualifications:
  • Bachelor's degree in Mechanical Engineering, Materials Engineering, or Biomedical Engineering.
  • A minimum of 5 years of relevant experience or 3 years with an advanced degree, specifically in the development of ISO 11607, ASTM Packaging Standards, and Medical Device Packaging Design.
  • Proficiency in SolidWorks or equivalent CAD software.
  • Strong critical thinking skills, capable of working with moderate guidance in specialized areas.
  • Ability to manage multiple projects of varying complexities simultaneously.
  • Experience working as part of a cross-functional team, collaborating with professionals from marketing, sales, clinical, regulatory, medical affairs, quality, and manufacturing.
  • Familiarity with medical device design control processes and the creation and maintenance of design control documentation.