Project Manager, R&D (Remote)

Getinge•Fraser, MI

8d•$100,000 - $135,000•Remote

About The Position

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.

Requirements

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 project lead role or project management role in medical devices
Excellent Communication and cross-functional coordination skills
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.
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.

Nice To Haves

PMP Certification preferred

Responsibilities

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