*Labeling & Packaging Engineer 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 * Bachelors 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 * Masters 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 by Jobble
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