Project Manager

Project Manager, Labeling & Packaging – Medical Devices

Location: Santa Clara, CA

Work Type: Onsite Required

The Project Manager will lead cross-functional teams in the development, implementation, and management of labeling and packaging solutions for our medical device products. This role requires deep expertise in medical device labeling regulations, packaging technologies, and project management to ensure compliance with global standards while driving efficiency and innovation. The Project Manager will oversee all aspects of labeling and packaging projects from conception through launch, acting as the primary liaison between regulatory, R&D, manufacturing, and quality teams.

Responsibilities

Lead cross-functional teams to develop and implement labeling and packaging strategies for new and existing medical device products

Develop and maintain project plans, timelines, budgets, and resource allocations for labeling and packaging initiatives

Coordinate with Regulatory Affairs to ensure compliance with FDA, ISO, MDR, and other relevant global regulatory standards

Manage the end-to-end process for labeling changes, updates, and new development from initiation to implementation

Collaborate with product development, manufacturing, and regulatory teams to create and release labeling components

Lead label review activities and maintain approval processes for labeling content and packaging materials

Identify and implement continuous improvement initiatives to enhance labeling and packaging processes, quality, and cost-effectiveness

Monitor project progress, identify risks, and develop mitigation strategies

Coordinate translations of package labeling through internal or external sources as needed

Prepare regular updates and reports for senior management on project status

Support audits and inspections related to labeling and packaging compliance

Requirements

Bachelor’s degree in Engineering, Life Sciences, Packaging, or related field

Minimum of 5 years of experience in the medical device or pharmaceutical industry, with direct experience in labeling and/or packaging

At least 3 years of project management experience leading cross-functional teams

Knowledge of US and international medical device regulations related to labeling and packaging

Experience with document control systems, change management, and quality management systems

Strong understanding of medical device packaging materials, standards (ISO, ASTM), and validation requirements

Excellent communication and presentation skills with the ability to influence stakeholders

Proven ability to manage multiple projects simultaneously while maintaining high quality standards

Experience with project management methodologies and tools (MS Project, Excel, PowerPoint)

Knowledge of package engineering principles and labeling requirements for sterile medical devices

Bonus Qualifications

Master’s degree in Engineering, Business, or related field

Project Management Professional (PMP) certification or equivalent

Experience with PLM, ERP systems, or labeling databases

Knowledge of sustainable packaging practices and environmentally friendly materials

Six Sigma or Lean certification with demonstrated process improvement successes

Experience with graphic design programs (e.g., Adobe Illustrator)

Direct experience with medical device submissions (510(k), PMA)

Background in design control processes for medical devices

Experience managing labeling for Software as a Medical Device (SaMD) products

Experience implementing automated labeling solutions or systems

Eight Eleven Group (Brooksource) provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.