Project Manager, R&D - Pleasanton, CA

Getinge•Pleasanton, CA

55d•$118,000 - $140,000

About The Position

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.

Requirements

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
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
Excellent leadership, analytical, problem-solving, and decision-making capabilities.
Strong written and verbal communication skills, with the ability to effectively communicate with diverse stakeholders.
Skilled at working with international teams.
Deep understanding of medical industry standards and compliance requirements.
Experience in leading tasks/projects through a structured, phase-gate process
Lead and manage technical meetings with cross-functional members
Excellent interpersonal, verbal, and written communication skills; strong technical writing skills
Ability to listen, convey empathy, and provide support
Ability to resolve conflict and build team unity
Ability to lead and manage a group of people
Task oriented and driven to complete assignments on schedule
Must have the ability to effectively interface with both technical and non-technical personnel.

Responsibilities

Manage all phases of the project lifecycle, from initiation and planning to execution, monitoring, control, and closure.
Develop comprehensive project plans, including defining project scope, goals, deliverables, timelines, and budgets.
Lead and collaborate with multidisciplinary teams, including physicians, nurses, IT professionals, and administrators, to ensure effective project execution and communication.
Monitor organizational spending habits, allocate resources effectively, and manage project budgets responsibly.
Maintain detailed project documentation and provide regular, transparent reports and status updates to stakeholders, including senior leadership and external partners.
Navigate and support organizational change to ensure smooth adoption of new systems or processes by staff, addressing resistance and concerns
Monitor project spend habits, allocate resources effectively, and manage project budgets responsibly.
Identify potential project risks and bottlenecks proactively, developing mitigation plans and effectively resolving issues as they arise.
Maintain regular, transparent communication with all stakeholders, providing clear status updates, managing expectations, and documenting project progress.
Implement quality control processes to ensure deliverables meet organizational standards and improve overall operational efficiency.
Drive organizational change management efforts related to project implementation, ensuring smooth transitions and staff adoption of new processes or systems.
Lead and coordinate multidisciplinary teams, including clinical staff, IT professionals, vendors, and administrative personnel, fostering effective communication and collaboration.