Project Manager, R&D (Remote)

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 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.

Job Responsibilities and Essential Duties :

• 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

Required Knowledge, Skills and Abilities:

• 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.

Minimum Requirements:

• 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 project lead role or project management role in medical devices
• Excellent Communication and cross-functional coordination skills
• PMP Certification preferred

Quality Requirements:

• 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 have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions:

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
• Office or production environment
• May work extended hours during peak business cycles.
• Domestic and International travel up to 20%

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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

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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.