Technical Project Manager

BioSpace has been engaged to help our client, a global provider of Point of Care (POC) medical diagnostic systems and solutions, to hire a highly motivated individual to support the CEO in the planning and production of the organization's proprietary 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 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