Project Manager
- 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
- E nsure the timely release of critical deliverables within the project
- E nsure 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
- E ffective 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
- 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)
- W orking knowledge of FDA and International Standards requirements as related to capital equipment and disposables
- E x perience with Microsoft Project, JIRA, Antura or other project management software
- E x perience in leading tasks/projects through a structured, phase-gate process
- Lead and manage technical meetings with cross-functional members
- E xc ellent interpersonal, verbal, and written communication skills; strong technical writing skills
- W e l l 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 .
- 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
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