Description We are looking for an experienced Project Manager/Senior Consultant with a strong background in managing projects within the medical device industry. This role focuses on digital applications and emphasizes risk management, particularly for ensuring compliance with evolving security standards. The position is Contract with potential for long-term employment and is located in Deerfield, Illinois.
Responsibilities:
Manage and oversee digital projects within the medical device space, ensuring all aspects meet regulatory compliance standards.
Implement risk management strategies to address security concerns related to medical device applications and patient identity protection.
Lead projects aligned with international standards such as IEC 62304, ensuring adherence to software development lifecycle processes.
Coordinate Agile project management methodologies to drive efficient and effective delivery.
Collaborate with cross-functional teams to ensure hardware and firmware integration meets project requirements.
Develop and maintain project budgets, timelines, and deliverables to ensure successful completion.
Facilitate communication between stakeholders to address technical and regulatory challenges.
Conduct evaluations and provide guidance on medical device regulations and software guidelines.
Ensure compliance with federal and industry standards for medical device software.
Provide leadership in resolving differences between firmware and software functionalities within projects. Requirements - Minimum of 7 years of project management experience, with a focus on medical devices.
Strong knowledge of IEC 62304 and its application to software development in medical devices.
Proven expertise in Agile methodologies and software development lifecycle processes.
Familiarity with hardware and firmware integration in medical device projects.
PMP certification is preferred.
Solid understanding of medical device regulations and development processes.
Experience managing project budgets and timelines.
Ability to communicate effectively with technical and non-technical stakeholders. Technology Doesn't Change the World, People Do.®
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