Remote: Director of Project Management (236849)

Description

The client is looking for a Program Manager to assist with a commercial re-launch of an infusion pump system that has updates to the base design, improved work flows and user interfaces. The device is being developed with a partner and the program manager will need to manage the program, co-ordinate and interface with the partners, lead the effort to resolve technical issues and challenges, negotiate with and influence the partners and project stakeholders to ensure requirements and timelines are met, setting up future-state work packages and other tasks to ensure program success. The candidate must have previous experience leading electro-mechanical medical device programs, strong leadership/management skills and ability to get partners/vendors aligned and onboard with project plan and expectations.

Skills/Requirements

• Familiarity with FDA, ISO, and other global medical device regulations and compliance standards. Proficiency in navigating through concept, design, development, testing, validation, and launch stages. Understanding and applying risk management frameworks (e.g., FMEA) for medical devices.
• Ability to define clear, strategic objectives for the program that align with both internal stakeholders and external partners. Capacity to foster collaboration across diverse teams, including R&D, Quality, Regulatory Affairs, and Marketing. Skills to mediate and resolve conflicts between marketing and other stakeholders or external partners.
• Strong interpersonal skills to develop trust with internal stakeholders and external partners. Ability to set realistic goals, manage expectations, and communicate trade-offs effectively. Competence in negotiating with external partners to ensure they meet contractual obligations and performance milestones.
• Adaptability to switch between project management styles depending on the phase or needs of the project. Ability to manage project resources, including budgets, timelines, and human resources effectively. Strong analytical and problem-solving skills to anticipate challenges and develop actionable solutions.
  
  

Remote: Director of Project Management (236849)

About Black Diamond Networks

Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.