SD_Project Manager III

Project Manager

We are seeking an execution-focused Project Manager to lead and deliver multiple projects within a regulated healthcare/medical diagnostics environment. This role emphasizes strong project execution, coordination, and delivery, ensuring projects are completed on time, within scope, and within budget.

• Lead and manage end-to-end project execution for new product development initiatives.
• Develop and maintain detailed project plans, including timelines, resources, dependencies, and budgets.
• Coordinate cross-functional teams to ensure alignment and successful project delivery.
• Monitor project progress, identify risks, and implement mitigation strategies.
• Conduct milestone reviews, capacity planning, and progress tracking.
• Ensure adherence to design control processes and regulatory standards.
• Manage project budgets and optimize resource allocation.
• Act as the primary point of contact for stakeholders, providing regular updates and reporting.
• Facilitate collaboration, knowledge sharing, and continuous improvement across teams.
• Apply Waterfall and hybrid Agile methodologies as needed to support project execution.

• Bachelor's degree in Science, Engineering, Business, or a related field.
• 6-8 years of project/program management experience.
• Experience in Medical Diagnostics, IVD (In Vitro Diagnostics), or related healthcare industry.
• Strong knowledge of Design Control processes and regulated environments (FDA, ISO standards).
• Proven experience managing budgets and multiple concurrent projects.
• Strong stakeholder management and communication skills.
• PMP Certification (preferred).

• Experience with Agile or hybrid project methodologies.
• Master's degree in a related field.
• Experience with clinical validation, biomarker development, or regulatory submissions.
• Familiarity with tools such as Planisware, Jira, Smartsheet, Trello, Lucidchart, ADO, MS Office, and Google Suite.

• Project Execution & Delivery
• Risk Management & Problem Solving
• Budget & Resource Management
• Stakeholder Communication
• Cross-functional Team Leadership
• Regulatory & Compliance Knowledge

• This is a backfill role requiring immediate contribution.
• The ideal candidate is detail-oriented, highly organized, and thrives in fast-paced, regulated environments.
• Ability to manage multiple priorities and drive results is essential.