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Project Director Jobs

Company

Medix™
Address Del Mar, CA, United States
Employment type FULL_TIME
Salary
Category Medical Equipment Manufacturing
Expires 2023-07-26
Posted at 10 months ago
Job Description

Medix Life Sciences is looking to hire a Project Director to join a renowned Diagnostic and Medical Device Organization located in San Diego, CA.

Overview:

  • The R&D Project Director will lead R&D teams to design, conduct research and development studies.
  • This person will also participate in decision making regarding research priorities for effective and efficient product development progression;analyze data and recommend further study direction; in addition, they must be able to lead a team of one or more of scientist(s), research associate(s) and research technician(s) for daily project activities.

Responsibilities:

  • Develop research plan, design experiments and outline research procedures to be followed
  • Literature/ patent search and analysis for project development
  • Lead one or more R&D teams to develop new projects from prototype to manufacture transfer and regulatory submission
  • Prepare documents for V&V activities and design control phase review
  • Identify and provide training to subordinate personnel to carry out research
  • Write clinical study protocol, conduct clinical evaluation; Perform clinical data analysis and write study report
  • Maintain laboratory equipment
  • Participates in decision making regarding research priorities of the department; and provides information on feasibility of prospective projects
  • Write/review study reports to assists RA department for regulatory submission
  • Manage the projects to meet project deadlines
  • Prepare reports for participated projects
  • Provide support to other department members as needed; and lead the investigation on customer's product complaint and troubleshooting for the production
  • Write manufacture documents for production transfer and the execution of transfer

Education / Experience

  • 2-3 years of experience at manager position in assay development and improvement process in a quality system environment
  • Lateral flow "Immunoassay" in IVD industry
  • Bachelor's degree or above with 10 years' experience in a Scientist role in the IVD industry
  • Experience of conducting clinical trial study and FDA 510K submission
  • Experience in "Immunoassay" development

Schedule:

  • Monday- Friday 8am-5pm

Base Salary:

  • $130,000-$160,000

#medixwest