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Getinge · 19 hours ago

Project Manager, R&D - Pleasanton, CA

Pleasanton, CA

Full-time

Onsite

Mid, Senior Level

$118K/yr - $140K/yr

5+ years exp

Getinge is a company dedicated to making life-saving technology accessible for more people. They are seeking a passionate and detail-oriented Project Manager to oversee the planning, execution, and closure of medical device projects, ensuring they are delivered on time and meet compliance and quality standards.

BiotechnologyHealth CareLife ScienceMedicalMedical Device

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

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

Qualification

Medical Device ExperienceQuality Management SystemsProject ManagementProject Management SoftwareFDA Standards KnowledgeTeam CoordinationAnalytical SkillsLeadership SkillsCommunication SkillsConflict Resolution

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

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

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