Project Manager, R&D; Remote

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Date:
Feb 10, 2026

Location:

Fraser, MI, US

Remote Work: 5 days at home (fully remote)

Salary Range: $100,000-$135,000/annually + 5% STIP

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.

The Project Manager will be responsible for the leadership of complex cross-functional projects related to the development and/or sustainment of Class I and II medical device development and remediation projects within an FDA and ISO 13485 regulated environment. 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 and drive project timelines, assemble required project teams, track schedule and deliverables, and maintain effective communication throughout the project.

• Lead cross-functional project teams in support of Class I and II 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 day-to-day project execution, schedules, milestones, and cross-functional task coordination.
• Maintain project plans, action logs, risk registers, and documentation aligned with FDA design controls (21 CFR 820.30).
• Ensure readiness for design reviews, design freezes, and V&V gates, coordinating inputs from R&D, QA, RA, Manufacturing, and Lab teams.
• Support preparation of design verification and validation plans, protocols, and timelines.
• Track project dependencies, identify risks, escalate blockers, and ensure on-time delivery.
• May assist in coordination of documentation for regulatory submissions (510(k), De Novo)
• Communicate project status to the Head of R&D and stakeholders with clear updates and metrics.
• Ensure 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
• Identify, support and promote new concepts and initiatives related to Project Management within the organization

• Experience with Microsoft Project 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)
• Strong understanding of design controls, V&V processes, and FDA Class I/II device requirements
• Working knowledge of FDA and International Standards requirements as related to capital equipment and disposables.
• BS in Engineering discipline (e.g., Systems, Biomedical, Electrical or Software Engineering) or equivalent experience
• Strong understanding of design controls, V&V processes, and FDA Class I/II device requirements
• Minimum of 3+ years in a project lead role or project management role in medical devices
• Excellent Communication and cross-functional coordination skills
• PMP Certification preferred

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must…