Project Manager, R&D - Pleasanton, CA
GetingeAbout the role
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Position Overview
We are seeking a passionate and detail-oriented Project Manager to join our team. The ideal candidate will be a dynamic, self-starter, responsible for overseeing the planning, execution, and closure of medical device projects. This role requires a blend of strong organizational skills, industry knowledge, and leadership to ensure projects are delivered on time, within budget, and meet the highest standards of compliance and quality.
Key Responsibilities
- Project Lifecycle Management: Manage all phases of the project lifecycle, from initiation and planning to execution, monitoring, control, and closure.
- Project Planning and Execution: Develop comprehensive project plans, including defining project scope, goals, deliverables, timelines, and budgets.
- Team Leadership and Coordination: Lead and collaborate with multidisciplinary teams, including physicians, nurses, IT professionals, and administrators, to ensure effective project execution and communication.
- Resource and Budget Management: Monitor organizational spending habits, allocate resources effectively, and manage project budgets responsibly.
- Stakeholder Communication: Maintain detailed project documentation and provide regular, transparent reports and status updates to stakeholders, including senior leadership and external partners.
- Change Management: Navigate and support organizational change to ensure smooth adoption of new systems or processes by staff, addressing resistance and concerns
- Resource and Budget Management: Monitor project spend habits, allocate resources effectively, and manage project budgets responsibly.
- Risk & Issue Management: Identify potential project risks and bottlenecks proactively, developing mitigation plans and effectively resolving issues as they arise.
- Stakeholder Communication: Maintain regular, transparent communication with all stakeholders, providing clear status updates, managing expectations, and documenting project progress.
- Quality Assurance: Implement quality control processes to ensure deliverables meet organizational standards and improve overall operational efficiency.
- Change Management: Drive organizational change management efforts related to project implementation, ensuring smooth transitions and staff adoption of new processes or systems.
Qualifications
Required:
- BS in engineering, Business Management, Project Management, or a related field.
- Minimum of 5+ years of proven project management experience in medical devices or other regulated industry
Skills, and Abilities
- Proficiency in project management software with Microsoft Project, JIRA, Antura or other project management software
- Medical Device experience including thorough understanding of Medical Device Quality Management Systems (ISO 13485, 21 CFR 820, ISO 14971)
- Working knowledge of FDA and International Standards requirements as related to capital equipment and disposables
- Team Coordination: Lead and coordinate multidisciplinary teams, including clinical staff, IT professionals, vendors, and administrative personnel, fostering effective communication and collaboration.
- Excellent leadership, analytical, problem-solving, and decision-making capabilities.
- Strong written and verbal communication skills, with the ability to effectively communicate with diverse stakeholders.
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