Technical Project Manager - Medical Devices

Santa Clara, California
Salary + bonus + benefits
Mar 01, 2021
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

Micropoint Bioscience, Inc., a global provider of Point of Care (POC) medical diagnostic systems and solutions, is seeking a highly motivated individual to support the CEO in the planning and production of MBI’s devices.

Job duties include:

  • Overall responsibility to develop and implement the project management processes, coordinate with stakeholders to define, prioritize and track project resources
  • Manage the products and work closely with scientists, engineers and the finance team via processes that optimize the efficiency and qualify
  • Lead cross-functional and technical teams to plan and execute multiple projects and initiatives
  • Create and monitor overall project schedules, issues, risks and timelines
  • Prepare, maintain, and present monthly project updates, action plans and status reports for CEO
  • Work closely with product managers, R&D and Manufacturing teams for product transfer, assay development, mechanical engineering, process engineering to drive successful project execution
  • Maintain QMS and documentation for audits
  • Maintain a high standard of product quality in compliance with ISO, FDA and CE criteria
  • Participate in new product verification, validation, and implementation to enter the manufacturing phase
  • Other supportive duties as assigned

Job qualifications include:

  • MS/BS in biology or chemistry or related engineering fields with at least 5 years of project management experience
  • Strong project management skills, PMP certification preferred
  • Experience in Life Science, Biotech, or Medical Device industry is a must
  • Product development experience (understanding of instrumentation, reagent and firmware) preferred
  • Experience in Quality System Regulations (QSR), GMP and ISO 13485 a plus
  • Strong interpersonal skills
  • Excellent verbal and written communication skills
  • Eligibility to work in the US