Job Description

• Improve continuously the Labeling and Packaging Process for which you are the owner and manage the interface to the stakeholders of the related disciplines.
• Lead and coordinate cross-functional project teams consisting of engineers, designers, regulatory experts, quality assurance specialists, and manufacturing personnel.
• Develop project plans, timelines, and budgets, and ensure adherence to project milestones and deadlines.
• Collaborate with stakeholders to define project scope, objectives, and requirements.
• Conduct risk assessments and implement mitigation strategies to ensure project success.
• Manage the design, development, transfer into production, testing, and validation of labeling and packaging solutions for medical devices.
• Ensure compliance with regulatory requirements, including FDA regulations, ISO 11607 standards, and other relevant guidelines.
• Drive continuous improvement initiatives to enhance efficiency, quality, and cost-effectiveness of labeling and packaging processes.
• Provide regular project updates to senior management and stakeholders, highlighting progress, challenges, and recommendations for course correction.
• Foster a culture of collaboration, innovation, and accountability within the project team.

Qualifications

• Bachelor's degree in engineering, packaging science, or a related field; advanced degree preferred.
• Minimum of 5 years of experience in project management, with a focus on labeling and packaging in the medical device industry.
• Proven track record of successfully leading complex projects from initiation to completion, on time and within budget.
• Strong understanding of regulatory requirements for labeling and packaging of medical devices, including FDA regulations and ISO standards.
• Excellent communication, leadership, and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Demonstrated problem-solving abilities and a proactive approach to identifying and resolving issues.
• Experience with project management tools and methodologies (e.g., Agile, Scrum, Six Sigma) preferred.
• PMP certification or equivalent is a plus.

Additional Information

As a Technical Project Leader specializing in Labeling and Packaging within the medical device industry, you will be responsible for driving the successful execution of projects from conception to completion. You will lead cross-functional teams to develop and implement innovative labeling and packaging solutions that comply with regulatory standards, meet customer requirements, and ensure product safety and efficacy.