Project Manager, Labeling & Packaging - Medical Devices
Location: Santa Clara, CA
Contract to Hire
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.
Job Types: Full-time, Contract
Pay: $60.00 - $70.00 per hour
Expected hours: 40 per week
Benefits:
Dental insurance
Health insurance
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to Friday
Ability to Commute:
Santa Clara, CA 95054 (Preferred)
Ability to Relocate:
Santa Clara, CA 95054: Relocate before starting work (Preferred)
Work Location: In person
Date Posted: 09 May 2025
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