Getinge · 1 hour ago
Project Manager
Wayne, NJ
Full-time
Onsite
Mid, Senior Level
$116K/yr - $140K/yr
4+ years expGetinge is a company dedicated to making life-saving technology accessible for more people. The Project Manager will lead complex cross-functional projects related to the development and sustainment of medical device systems, ensuring compliance and effective communication throughout all phases of the project.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Lead cross-functional project teams in support of Class I - III medical devices and/or CAPAs
Monitor and maintain awareness of new and current product regulations and standards
Develop and release all project-related deliverables, including project plan, schedule, and budget
Manage a project within standardized methods and project models such as Waterfall or Agile
Lead and support execution of technical and/or cross-functional project work
Ensure the timely release of critical deliverables within the project
Ensure all aspects of the project are in compliance to internal procedures
Understanding of group dynamics to influence team members
Develop and present periodic status reports
Effective communication with project stakeholders, local management, and global management
Demonstrate leadership when facing uncertainty
Instill confidence through leadership and actions
Understand group dynamics and use this knowledge to lead the project
Identify, support, and promote new concepts and initiatives related to Project Management within the organization
Qualification
Required
B S in Engineering discipline (e.g., Systems, Biomedical, Electrical or Software Engineering) or equivalent experience
Minimum of 4+ years of experience in medical device or other regulated industry
Minimum of 3+ years in task or project lead role
Domestic and/or international travel up to 20%
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
Experience with Microsoft Project, JIRA, Antura or other project management software
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
Well organized, detail oriented
Task oriented and driven to complete assignments on schedule
Must have the ability to effectively interface with both technical and non-technical personnel
Benefits
Health, Dental, and Vision insurance benefits
401k plan with company match
Paid Time Off
Wellness initiative & Health Assistance Resources
Life Insurance
Short and Long Term Disability Benefits
Health and Dependent Care Flexible Spending Accounts
Commuter Benefits
Parental and Caregiver Leave
Tuition Reimbursement
Company
Getinge
Getinge identifies customer issues and promotes clinical and economic benefits and follow and support the customer decision process.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$539.31M2017-10-19Post Ipo Equity· $539.31M
2002-06-28IPO
Leadership Team
C
Christoffer Å.
Chief Information Security Officer
Joanna Engelke
EVP Quality Compliance, Regulatory, Medical
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