Senior Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead intricate, cross-disciplinary new product development initiatives for in vitro diagnostic assays and diagnostic instrument systems.

• Oversee project planning and execution from the initial concept through to launch.

• Establish project scope, objectives, deliverables, success metrics, and governance structures.

• Create and sustain integrated project plans, including timelines, critical paths, dependencies, resource requirements, and key decision points.

• Relay project plans and modifications to team members and leadership.

• Foster team accountability and dedication to project plans.

• Identify potential risks, challenges, trade-offs, and necessary adjustments to achieve project goals.

• Monitor, evaluate, and communicate project performance, covering schedule, milestones, risks, resources, and budget.

• Provide status reports, forecasts, and escalate issues to leadership as needed.

• Ensure timely completion of deliverables in line with commitments, design control standards, and company protocols.

• Lead and coordinate cross-functional project teams, facilitating decision-making, issue resolution, and alignment across various functions and external partners.

• Collaborate with R&D, Operations, Regulatory Affairs, Quality, Clinical Affairs, Finance, Marketing, and external development partners.

• Execute additional responsibilities as assigned.

⛳️ Requirements

• A Bachelor's degree in science, engineering, business administration, or a related field is required.

• Minimum of 7 years of project management experience in leading cross-functional product development projects.

• Substantial experience managing complex, multifaceted projects from concept to launch.

• Direct experience in managing FDA-regulated in vitro diagnostic (IVD) product development projects.

• Proven history of guiding IVD products through FDA clearance or approval and successful commercial launch in the U.S. market.

• Strong familiarity with medical device design control requirements and product development processes.

• Experience in design planning, design reviews, risk management, verification and validation, transfer, regulatory submission, and launch readiness.

• Background in IVD products, including assay and/or diagnostic instrument development.

• Experience working within Quality Management Systems that comply with FDA 21 CFR Part 820 and relevant medical device regulations.

• Project management qualification (PMP) or an equivalent credential is preferred.

• Advanced project management abilities and hands-on experience, ideally in the diagnostic sector.

• Successful leadership of product development projects characterized by significant technical, regulatory, operational, and/or cross-functional complexity.

• Aptitude for conducting critical path analysis, managing dependencies, assessing risks, and scenario planning.

• Exceptional problem-solving and decision-support abilities.

• Capacity to prioritize competing demands, manage workloads and timelines, and handle multiple projects concurrently.

• Ability to operate autonomously with minimal supervision while influencing and collaborating with peers, functional leaders, senior stakeholders, and external partners.

• Capability to meet stringent deadlines and thrive under pressure in a dynamic work environment.

• Outstanding interpersonal, organizational, written, and verbal communication skills.

• Fundamental understanding of IVD product development, including assay and/or instrument development, engineering, verification and validation, regulatory, quality, clinical, manufacturing, transfer, and launch activities.

• Willingness to travel up to 20% of the time.

🏝️ Benefits

• Travel as necessary to support project teams and achieve key milestones.

• Option for remote work.

• Travel reimbursement associated with the required 20% travel.