Project Manager 3 Global Labeling

Maxonic Inc.; Sunnyvale (CA); On-site; USD 102,000 - 146,000; Full time

Job summary

Maxonic is seeking a Project Manager 3 Global Labeling in Sunnyvale, CA to lead labeling programs for medical devices. You will plan, execute, and oversee cross-functional labeling projects across geographies, ensuring regulatory alignment and on-time delivery.

The role requires a four-year engineering degree, 5+ years in the medical device field, and strong collaboration with Regulatory, Manufacturing, Quality, and IT teams. Onsite work with travel about 10% is expected.

Qualifications

• Bachelor's degree in engineering or equivalent.
• 5+ years in the medical device field.
• Experience in global multi-discipline environment (Regulatory, Manufacturing, Quality, IT, Logistics).
• Strong written and verbal communication for internal/external stakeholders.
• Proven ability to manage labeling projects and timelines.
• Willingness to travel ~10% domestically and internationally.

Responsibilities

• Manage labeling projects for product development and global rollout.
• Develop, plan, and execute labeling programs ensuring regulatory alignment.
• Coordinate with cross-functional teams and external vendors.
• Lead process improvements using Six Sigma and/or Agile methodologies.
• Prepare reports and communicate project status to stakeholders.

Skills

Project management

Global labeling

Regulatory compliance

Cross-functional teamwork

Communication

Problem solving

Leadership

Travel willingness

Education

Bachelor's degree in Engineering

Tools

Tableau

Smartsheet

Microsoft 365

SAP

Job description

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Project Manager 3 Global Labeling.

Job Description:

Job Title: Project Manager 3 Global Labeling

Job Type: Full-time

Job Location: Sunnyvale, CA

Work Schedule: Onsite

Pay Rate: $90, Based on experience

Description:

Primary Function of Position:

• We are looking for an individual to manage labeling projects associated with the development of 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 our 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.
• 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 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.

Skills, Experience, Education, & Training:

• 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 written 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%).

About Maxonic:

Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.