Associate Director, Project Management

Position Summary:

As an Associate Director, Project Management, you will work with cross-functional teams across locations to plan, execute, and monitor point-of-care CLIA waived IVD development project(s) to enable timely commercialization in a fast-paced environment. You will develop and manage detailed project timelines, identify risks and issues, develop management and mitigation plans, and facilitate communication within the team as well as to senior leadership. We are seeking a project manager who has IVD design control and dual 510(k) / CLIA waiver submission experience and a technical background.

Responsibilities

• Collaborate with cross-functional stakeholders across locations to develop, manage, execute, and track CLIA waived IVD development project plans through feasibility and planning, development, verification, validation, design transfer, and commercialization. Facilitate use of project planning software by team so that timelines include and provide visibility to cross-functional dependencies.
• Provide guidance to the team on how to manage and communicate changes that may impact key project milestones.
• Work with team to monitor progress, identify issues and risks, develop management and mitigation strategies, and make appropriate trade-offs to optimize business needs like time-to-market.
• Ensure key milestones stay on track by monitoring dependencies, anticipating and addressing bottlenecks early, and partnering with team members to recommend creative and acceptable solutions.
• Cross-functional activities to track and coordinate include phase exit deliverables, design outputs like labeling and DMRs, SW release and validation, clinical study dependencies, process validation, contract manufacturing, change control, etc.
• Manage core team meetings with team members who are in-person and remote. Generate agendas, document decisions and minutes, and follow up on action items. Similarly manage sub-team meetings as needed. Ensure roles and responsibilities are understood.
• Develop and implement right level of process to ensure smooth and predictable project execution.
• Facilitate open and timely communication across functions, including Product Management, Assay Development, Hardware Development, Software Development, Systems Engineering, Manufacturing, Operations, Supply Chain, Regulatory, Quality, Clinical, Commercial.
• Effectively communicate project status, issues and risks, and management and mitigation strategies to key stakeholders, including project updates to senior leadership at review meetings or ad hoc escalations. Communicate resource constraints.

Qualifications: Education/Skills/Requirements

• Bachelor's, Master's or higher degree in the biological sciences, engineering or related technical fields.
• 5+ years of project management experience in IVD product development under design control. Experience managing IVD projects from feasibility through commercialization with dual 510(k) / CLIA waiver submission is a plus.
• Experience collaborating with cross-functional teams to build and manage detailed project timelines and dependencies in project planning software and using software to monitor plan execution and generate reports. High proficiency in SmartSheets (workflows, conditional formatting, milestone reports, dashboards, Gantt charts) is a plus.
• Experience working on large projects, addressing risks and issues, facilitating trade-off decisions, and delivering projects on time. Leading non-co-located teams in a start-up environment is a plus.
• Experience leading cross-functional core team meetings, developing agendas, documenting minutes, and tracking action items.
• Excellent oral, written, and presentation skills. Ability to communicate effectively and establish credibility with technical and non-technical stakeholders including executive staff.
• Agility and flexibility to thrive and succeed in an entrepreneurial environment and navigate ambiguity and competing priorities.
• Leadership, maturity, good judgment, negotiation skills, ability to influence, technical acumen, and attention to detail or the big picture as appropriate are essential to success in this role.