Job Description

Position Title: Project Manager III

SUMMARY:

The Project Manager will lead the design control efforts in the development of point-of-care molecular diagnostic products and will be a primary interface in cross-disciplinary development or improvement teams comprised of Operations, Engineering, Research and Development, Marketing/Commercialization, Quality, Regulatory, and Clinical Affairs. Responsibilities touch all aspects of the product development cycle including Design Controls, Design Inputs, Feasibility, Timelines, Design History Files, Risk Management, V&V and traceability, Clinical Trials and managing of regular project meetings and deliverable milestones. The Project Manager will additionally be involved in the technical aspects of the projects and will continually analyze and manage project risks to enable successful project completion. They will identify, resolve, or escalate project issues and ensure product development or improvement efforts adhere to product development processes and design control standards. This is a high-profile position with executive level interface requirements, and requires a high degree of diligence, attention to detail, and excellent oral and written communication skills.

RESPONSIBILITIES:

• Project Timelines and Tracking
• Driving projects to achieve planned timelines
• Oversee and contribute to Project Requirements and improvements
• Maintain accurate GANTT from project inception through commercial realization
• Project Planning through all development and execution phases
• Management of all product validation deliverables including technical staff
• Hold regular project meetings and facilitate stakeholder input
• Regularly communicate with project stakeholders to ensure project goals or changes in scope are in accordance with business objectives.

KNOWLEDGE AND SKILLS:

• Hands on experience with chemistry and engineering processes related to IVD product development and manufacturing
• Working knowledge of validation development and execution
• Excellent presentation, communication, technical report writing and GANTT development and management
• Possess rapid decision-making abilities and exceptional interpersonal skills
• Ability to work independently in a multidisciplinary team environment
• Highly motivated individual who is driven by milestone adherence
• Presentation skills intended for executive level management
• Cross-functional team management
• Comprehensive knowledge of Microsoft suite of software including fluency in MS Project
• Comprehensive knowledge of Document control processes (MasterControl, Agile or equivalent)

EDUCATION/EXPERIENCE REQUIRED:

• Bachelor's Degree in Molecular Biology, Biochemistry, Engineering or related field
• Minimum of 3 years in a technical role in the IVD industry with an additional 5 years in a project management role with experience managing on-market 510(k) regulated IVD product improvements
• Six-Sigma and/or PMP certification a plus