Description Engineering Project Manager IILocation: Raleigh, NC
Employment Type: 38 Week Contract
About the RoleJoin a mission-driven organization where your work directly contributes to improving and saving lives. We are seeking an experienced
Technical Project Manager to lead the development and implementation of a
Software as a Medical Device (SaMD) product. In this role, you will be responsible for overseeing all technical execution aspects of the project, ensuring adherence to quality, cybersecurity, and regulatory standards-while delivering on time and within budget.
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Key ResponsibilitiesProject Leadership & Execution- Develop and manage detailed project plans, timelines, dependencies, and budgets to ensure successful and timely delivery.
- Partner with stakeholders to co-create comprehensive project plans and maintain alignment and accountability throughout execution.
- Integrate the technical project plan into the broader program strategy and collaborate closely with the Program Manager.
- Lead the technical execution of the project, partnering with development teams to drive accountability for milestone commitments.
- Identify, assess, and mitigate project risks and issues, ensuring prompt resolution and minimal impact to timelines.
- Act as a hands-on problem solver-conduct root-cause analysis, propose solutions, and remove technical blockers.
- Ensure all deliverables meet the highest quality standards and comply with applicable regulatory and cybersecurity requirements.
- Maintain complete documentation, ensuring project artifacts, lessons learned, and knowledge are properly archived and shared.
Stakeholder Management- Identify, analyze, and prioritize stakeholder needs and expectations.
- Develop effective communication strategies to keep all stakeholders informed, aligned, and appropriately engaged.
- Provide clear updates on project progress, issues, and risks.
- Manage expectations and ensure stakeholders are satisfied with deliverables and outcomes.
Requirements QualificationsRequired- Bachelor's degree in Computer Science, Engineering, or a related field.
- 8+ years of relevant professional experience.
- Minimum 4 years of technical project management experience, preferably supporting SaMD or regulated software.
- Strong understanding of software development life cycles and regulatory requirements for medical products.
- Proven experience leading cross-functional teams across multiple sites.
- Background in product development or quality, with involvement from concept through production launch.
- Analytical mindset with excellent problem-solving skills.
- Thrives in a fast-paced environment with changing priorities.
- Strong communication skills and a metrics-driven approach.
Preferred- Experience with sustaining engineering activities.
- PMP or other project management certification.
- Experience with Agile methodologies.
- Familiarity with software development tools and technologies.
- Knowledge of medical device regulations and industry standards.
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