Technical Project Manager - Medical Devices
- Employer
- Micropoint Bioscience, Inc.
- Location
- Santa Clara, California
- Salary
- Salary + bonus + benefits
- Posted
- Mar 01, 2021
- Discipline
- Administration, Manufacturing & Production, Operations, Process, Marketing, Product Development/Management
- Hotbed
- 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