Program Manager, Cardiac Surgery, Wayne, NJ

Getinge•Wayne, NJ

About The Position

The Program Manager is responsible for the leadership of multiple, complex, cross-functional projects supporting the Cardiac Surgery Product Area (PA). This includes all aspects of the product lifecycle for electro-mechanical medical device systems with embedded software, from concept development through product launch and sustaining activities. The Program Manager will establish and maintain the structure for multiple projects, ensuring alignment with business objectives, regulatory requirements, and quality standards. Project assignments are at the discretion of the supervisor and based on business needs.

Requirements

BS in Engineering discipline (e.g., Systems, Biomedical, Electrical, Chemical, or Software Engineering) or equivalent relevant experience.
Minimum of 7+ years of experience in the medical device or other regulated industry.
Minimum of 5+ years in a task or project lead role.
Extensive experience in medical device development, with a thorough understanding of Medical Device Quality Management Systems (ISO 13485, 21 CFR 820, ISO 14971).
Working knowledge of FDA and international standards requirements for capital equipment and disposables.
Demonstrated ability to lead and manage technical meetings with cross-functional teams.
Proficiency with project management software (e.g., Microsoft Project, JIRA, Antura).
Experience leading projects through structured, phase-gate processes.
Excellent interpersonal, verbal, and written communication skills; strong technical writing skills.
Well-organized, detail-oriented, and able to manage multiple priorities.
Task-oriented and driven to complete assignments on schedule.
Ability to effectively interface with both technical and non-technical personnel.
Demonstrated leadership in times of uncertainty and change.
PMP certification required within 36 months of starting position.
Domestic and/or international travel up to 20%.

Responsibilities

Lead diverse, cross-functional project teams in support of Class I-III medical devices and/or CAPAs.
Oversee all phases of assigned projects, including concept development, design, verification/validation, regulatory submission, product launch, and post-market activities.
Develop and release all project-related deliverables, including project plans, schedules, budgets, and reports.
Manage projects using standardized methods and models (e.g., Waterfall, Agile), ensuring compliance with internal procedures and external regulations.
Monitor and maintain awareness of new and current product regulations and standards (FDA, ISO, etc.).
Anticipate issues, mitigate risks, and ensure the timely release of critical deliverables.
Lead and support execution of technical and/or cross-functional project work.
Develop project timelines, assemble project teams, track schedules and deliverables, and maintain effective communication throughout the project lifecycle.
Communicate project status at defined intervals to stakeholders, local and global management, and escalate concerns as needed.
Represent the Engineering Program Management Office in local and global meetings/activities, as delegated.
Mentor and support Project Leaders and Project Managers; serve as a sounding board for less experienced team members.
Manage special and/or confidential projects at the discretion of senior leadership (VP, CTO, CEO).
Foster a culture of quality, compliance, and continuous improvement, adopting the “Beyond Compliance Quality Culture.”
Integrate environmental, health, and safety considerations into all aspects of work.