Job Summary: We are seeking an experienced Project Manager with a strong background in both Waterfall and Agile project management methodologies. The ideal candidate will have a proven track record of managing end-to-end project execution, particularly within the framework of ISO 13485. Hands-on experience with project planning tools such as Microsoft Project (MPP) and Smartsheet is essential. Additionally, the candidate should have experience handling various scenarios during project execution, especially in the case of Verification and Validation (V&V) failures, and be knowledgeable about the SAP ecosystem.
Key Responsibilities:
- Manage and oversee the entire project lifecycle from initiation to closure, ensuring all deliverables meet ISO 13485 standards.
- Utilize both Waterfall and Agile methodologies to plan, execute, and monitor projects, adapting as necessary to meet aggressive timelines.
- Develop detailed project plans using tools like Microsoft Project (MPP) and Smartsheet, and track progress against these plans.
- Identify, analyze, and resolve issues related to project execution, particularly V&V failures, by implementing effective corrective actions.
- Collaborate with cross-functional teams to ensure seamless integration and execution of project tasks.
- Maintain comprehensive project documentation and ensure all project records are up-to-date and compliant with regulatory requirements.
- Provide regular project updates to stakeholders, highlighting key milestones, risks, and mitigation strategies.
- Leverage knowledge of the SAP ecosystem to integrate project management processes with existing systems and tools.
Qualifications:
- Bachelor’s degree in Project Management, Engineering, Business Administration, or a related field.
- Minimum of 10+ years of experience in project management, with a focus on Waterfall and Agile methodologies.
- Proven experience in managing projects in compliance with ISO 13485 standards.
- Proficiency in project planning tools such as Microsoft Project (MPP) and Smartsheet.
- Strong problem-solving skills with experience in handling V&V failures and implementing corrective actions.
- Familiarity with the SAP ecosystem and its integration with project management processes.
- Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
- PMP, PRINCE2, or Agile certification is a plus.
Preferred Skills:
- Experience in the medical device industry or a similar regulated environment.
- Strong analytical and organizational skills.
- Ability to manage multiple projects simultaneously and meet tight deadlines.
