Project Manager - Cardiac Surgery, Wayne, NJ

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

The Project Manager will be responsible but not limited to the leadership of complex cross-functional projects related to the development and/or sustainment of electro-mechanical medical device systems and/or single use devices and/or CAPAs. Project assignment is at the discretion of the supervisor and is based on business requirements. Also responsible for all phases of the project, from Concept Development to Product Launch. Develop project timelines, assemble required project teams, track the schedule and

deliverables, and maintain effective communication throughout the project.

Job Responsibilities and Essential Duties

• 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.

Minimum Requirements

• BS in Engineering discipline (e.g., Systems, Biomedical, Electrical or Software Engineering) or equivalen 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%

Required Knowledge, Skills, and Abilities

• 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

Salary Range: $116 - $140K

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About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

• 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

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.