Medical Device Technical Project Leader Labeling/Packaging – Development (m/f/d)

Medical Device Technical Project Leader Labeling/Packaging – Development (m/f/d)

• Full-time

Company Description

We are on an exciting journey as we take an active role in creating the future of the digital healthcare ecosystem. You will decisively contribute to the way pharmaceutical products and medical devices are managed by taking advantage of the latest technological advances. If you are experienced in developing medical products and have a strong interest in modernizing the pharmaceutical industry, we are happy to offer you a place where you get the independence to creatively contribute to the future of healthcare.

As a listed MDAX company, Gerresheimer is a leading global partner to the healthcare and cosmetics industries. We generate sales of around 1.4 billion euros and are represented worldwide with about 10,000 employees. We work daily to improve the quality of life of patients worldwide.

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.