Project Manager, R&D (Remote)

With a reputed company Join our diverse teams of passionate people and a career that allows you to reputed company both personally and professionally. At reputed company we exist to reputed company life-saving technology accessible for more people. To reputed company a true difference for our customers - and to save more lives, we need team players, reputed company thinkers, and game changers. Are you looking for an inspiring career? You just reputed company it. Job Overview The Project Manager will be responsible for the leadership of reputed company cross-functional projects reputed company to the development and/or sustainment of Class I and II medical device development and remediation projects reputed company 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 reputed company phases of the project, from Concept Development to Product Launch. reputed company and drive project timelines, assemble required project teams, track schedule and deliverables, and maintain effective communication throughout the project. Job Responsibilities and Essential Duties:

• reputed company cross-functional project teams in support of Class I and II medical devices
• Monitor and maintain awareness of new and reputed company product regulations and standards
• reputed company and release reputed company project-reputed company 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 reputed company 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 reputed company the project
• Ensure reputed company aspects of the project are in compliance to internal procedures
• reputed company and present periodic status reports
• Effective communication with project stakeholders, local management, and global management
• Identify, support and promote new concepts and initiatives reputed company to Project Management reputed company the organization

Required Knowledge, Skills and Abilities:

• Experience with reputed company Project or other project management software
• Experience in leading tasks/projects through a structured, phase-reputed company process
• reputed company 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 reputed company 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 reputed company 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 reputed company role or project management role in medical devices
• Excellent Communication and cross-functional coordination skills
• PMP Certification preferred

Quality Requirements:

• Build Quality into reputed company aspects of their work by maintaining compliance to reputed company quality requirements.
• Ensure compliance to reputed company FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and reputed company with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend reputed company 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 reputed company 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 reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. $100,000-$135,000/annually + 5% STIP #LI-LG1 About us With a firm belief that every person and community should have access to the best possible care, reputed company 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. reputed company employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at reputed company: At reputed company, 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

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