PMO Medical Device

Lead operational excellence for a high-growth medical device startup.

About Opyflow

Opyflow is a leading consulting firm specializing in supply chain operations, procurement, and project management solutions. We are known for delivering measurable results and driving success through expertise and execution.

Our client, a successful and rapidly growing medical device startup, is seeking an experienced PMO Leader to be based on-site at their facility. This position is a key outsourcing opportunity through Opyflow, designed to support the client’s business expansion and operational efficiency.

About the Role

As the PMO Leader, you will establish and oversee the project management office (PMO) to ensure the company’s strategic objectives are met. This hands-on, on-site role requires close collaboration with senior leadership and cross-functional teams to drive project execution, improve processes, and maintain compliance in a fast-paced environment.

Key Responsibilities:

• Lead and manage multiple projects in the medical devices sector from initiation to closure.
• Coordinate multiple projects involving R&D, Engineering, Production, Quality, Supply chain and RA.
• Develop detailed project plans, timelines, and budgets.
• Coordinate and communicate with stakeholders, including clients, team members, and vendors.
• Monitor project progress, identify risks, and implement mitigation strategies.
• Ensure compliance with industry regulations and standards.
• Facilitate project meetings, providing clear and concise updates.
• Prepare and present project status reports to senior management and clients.
• Continuously improve project management processes and methodologies.
• Provide deep understanding and expertise in quality assurance and regulatory affairs (RA).

Qualifications:

• Bachelor's degree in Business Administration, Industrial Engineering, or a related field. A Master's degree is preferred.
• PMP or similar project management certification is highly desirable.
• Minimum of 10 years of experience in project management/Operations, with at least 3 years in the medical devices industry.
• Proven track record of successfully managing complex projects.
• Strong knowledge of medical device regulations and standards (e.g., FDA, ISO 13485).
• In-depth understanding of quality assurance processes and regulatory affairs.
• Excellent communication, leadership, and interpersonal skills.
• Ability to work effectively in a fast-paced, dynamic environment.
• Strong problem-solving skills and attention to detail.
• Proficiency in project management software