Engineer

2 weeks ago

Irvine, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Direct experience in Design development of combination products, or Medical Devices. Working knowledge of system engineering, risk management, usability, all the phases of design controls (end to end), global regulatory submissions, high volume manufacturing of devices and packaging including biologics.
  • Experience with plastic- injection molding, glass, rubber, hypodermic syringes will be highly desired.
  • Direct experience in designing and analyzing using 3D, 2D and FEA.
  • Direct design control, risk management, test method development, & testing experience in Combination products, Medical Devices.
  • Create, maintaining specification, protocol, and reports.
  • Clear and concise written and verbal communication cross functionally.
  • bility to prioritize and adapt in rapidly changing environment and stakeholders need.
  • B.S. in Mechanical, Biomedical, Industrial Engineering discipline
  • 3+ years of full time directly related experience in regulated industry (does not count internship/co-op/research work at the university/teaching assistant)
  • 8+ years direct experience in Pharma, BioPharm, or Medical devices.
  • Business: Ability to develop trade-off scenarios impacting business areas.
Requirements:
  • bility to make timely, high-quality decisions with less than perfect information and apply good engineering principles.
  • Sets clear and concise strategies and robust implementation plans ensuring business and patient impact.
  • Effective communication across all the levels within the organization to drive collaboration and decision-making.
  • Statistical analysis.
  • Usability & Regulatory experience.
  • Experience with plastic- injection molding, glass, rubber, hypodermic syringes will be highly desired.
  • Prototyping
  • Sets clear and concise strategies and robust implementation plans ensuring business and patient impact.
  • bility to develop trade-off scenarios.
  • Master's degree
  • Design for Six Sigma
  • 5+ years in regulated industry(does not count internship/co-op/research work at the university/teaching assistant

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