General Information:
* Start date: 10.3.2025
* Latest Start Date: 31.3.2025
* Planned duration: 18 months
* Extension (in case of limitation): not planned yet
* Workplace: Basel
* Workload: 100%
* Remote/Home Office: onsite
Tasks & Responsibilities:
Define project charter and scope in collaboration with the Device Development Leader, ensuring project assumptions, constraints, and scope are shared and understood within the organization.
Clearly plan project deliverables and forecast requirements, estimating team resources and budget.
Generate a comprehensive list of required documentation to ensure project information is readily accessible for seamless integration in collaboration with PMO.
Manage change management for project scope changes to assure constant stakeholder alignment.
Develop and maintain the project schedule, tracking progress.
Plan and manage the project budget, monitoring expenditures in collaboration with other governing committees.
Establish and maintain solid communication with internal and external stakeholders, providing updates and regular status reports.
Identify, monitor, and mitigate project risks and issues.
Allocate and manage resources in collaboration with the Device Development Leader.
Ensure project deliverables meet quality system requirements.
Must Haves:
BA/BS + a minimum of 15 years total work experience with at least 10 years of relevant business and/or technical experience in the medical device, pharmaceutical, or biopharmaceutical industry.
Experience in drug-device combination products is considered an asset.
At least 10 years of Project Management experience - PMP certification or equivalent is preferred.
Proven experience in project management, including planning, execution, and closure.
Strong leadership and team management skills.
Excellent communication and interpersonal skills.
Proficiency in project management software (e.g., MS Project, Smartsheet, Trello).
Solid understanding of project management methodologies (e.g., Agile, Waterfall).
Ability to manage multiple projects simultaneously and prioritize tasks effectively.
Strong foundation in engineering, biotechnology, or life sciences relevant to medical device development.
Understanding of clinical, regulatory, and manufacturing requirements.
Proven track record leading development projects with knowledge of project management methodologies and Design Control requirements.
Deep understanding of design controls, risk management, and quality systems (ISO 13485, FDA 21 CFR Part 820).
Adept at identifying project risks and implementing mitigation strategies.
Proven ability to cultivate, develop, and sustain high-performing teams.
Proven ability to communicate effectively with team members and stakeholders.
#J-18808-Ljbffr