Project Manager, R&D - Wayne, NJ jobs in United States
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Getinge · 1 day ago

Project Manager, R&D - Wayne, NJ

Getinge is a company dedicated to making life-saving technology more accessible. The Project Manager will lead complex cross-functional projects related to the development and sustainment of electro-mechanical medical devices, overseeing all phases from concept development to product launch.

BiotechnologyHealth CareLife ScienceMedicalMedical Device

Responsibilities

Lead cross-functional project teams in support of Class I - III medical devices
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
Develop and present periodic status reports
Effective communication with project stakeholders, local management, and global management
Demonstrate leadership when facing uncertainty
Understanding of group dynamics to influence team members and lead the project
Instill confidence through leadership and actions
Identify, support, and promote new concepts and initiatives related to Project Management within the organization

Qualification

Medical Device ExperienceRegulatory KnowledgeProject ManagementMicrosoft ProjectJIRACommunicationTechnical WritingLeadership SkillsDetail Oriented

Required

BS in Engineering discipline (e.g., Systems, Biomedical, Electrical or Software Engineering) or equivalent experience
Minimum of 3+ years in project lead role or project management role
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; must be 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
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
Domestic and/or international travel up to 20%

Preferred

Experience in medical device or other regulated industry

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 identifies customer issues and promotes clinical and economic benefits and follow and support the customer decision process.

Funding

Current Stage
Public Company
Total Funding
$539.31M
2017-10-19Post Ipo Equity· $539.31M
2002-06-28IPO

Leadership Team

C
Christoffer Å.
Chief Information Security Officer
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Joanna Engelke
EVP Quality Compliance, Regulatory, Medical
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Company data provided by crunchbase