Medical Device Global Labeling Project Manager

Pay Range: $85.00hr - $90.00hr

Job Overview:

Our client designs and manufactures highly complex surgical systems including cameras, instruments, and accessories for use in surgery. We are looking for an individual to manage labeling projects associated with the development of these products. The role is responsible for the development, planning, and execution of labeling projects that support business and operational goals. The successful candidate will interface with cross-functional stakeholders across the organization to act as a central hub of knowledge to manage information, communications, tasks, and timelines. The ideal candidate will have a passion for people, processes, and products, and strive to achieve positive customer experiences within global regulatory requirements.

Responsibilities:

• Develop, communicate, and implement project plans; monitor progress and performance against the plan; resolve problems, mitigate risk, and minimize delays.
• Identify scope, develop timeline, and align resources for labeling projects across multiple product lines and geographies to meet objectives. Drive multiple parallel projects with unique cross-functional team members.
• Review labeling updates for labeling content and accuracy to confirm alignment with regulatory requirements.
• Estimate costs, resources, and durations required to complete projects and tasks.
• Monitor activities, allocate resources, and assign tasks to ensure goals are met.
• Liaise with other areas in the organization to secure specialized resources and contributions for projects.
• Conduct project meetings and prepare reports to communicate the status of the project within and beyond the project team.
• Work through complex scenarios with project staff to assist and/or benchmark strategies to solve problems.
• Analyze and evaluate tools and processes; propose and implement accuracy and efficiency improvements.
• Foster continuous improvement by initiating and managing process improvement projects employing Six Sigma principles and/or Agile project management methodologies.
• Manage highly complex label content for the organization's diverse products (systems/capital equipment, software, instruments, and accessories).
• Interact with external and internal teams to drive labeling-related items and tasks to closure. Coordinate and support labeling activities with external print vendors, internal manufacturing stakeholders, and New Product Introduction (NPI) teams.

Requirements:

• Minimum four-year Engineering degree (bachelor's degree or equivalent) preferred; business or related field may be considered commensurate to work experience.
• Minimum 5 years professional history working in a medical device industry or equivalent experiences.
• Experience working in a structured global business environment with multiple disciplines such as Regulatory, Manufacturing, Quality, Information Technology, and Logistics.
• Ability to digest, distribute, and adjust communications to various members and levels of the organization.
• Strong ability to communicate verbally and in writing to internal and external customers in an organized manner.
• Self-starter who can independently thrive in a team environment to prioritize tasks and resolve problems.
• Highly organized with strong interpersonal, communication, analytical, and soft skills.
• Ability to build strong positive working relationships with radical candor.
• Enthusiastic individual with a passion to learn and develop project management and business skills.
• Familiar with Portfolio Management, Design Control, Risk Management, and Manufacturing Process Controls.
• Awareness of medical device regulatory standards and compliance requirements.
• Proficient user of Microsoft 365 or similar productivity tools.
• Proficient user of Tableau, Smartsheet, or similar project and data management software.
• Familiar with SAP, Agile, or similar enterprise software.
• Familiar with international, region-specific labeling requirements preferred.
• Familiar with a range of labeling methods preferred, such as thermal-transfer printing, pad printing, laser marking.
• Ability to travel domestically and internationally as needed to execute projects (approximately 10%).