Johnson and Johnson is currently seeking a Principal Packaging Engineer to join our team, located in Danvers, MA.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

1. Packaging Design and Development:
• Lead the design and development of packaging solutions for medical devices, considering factors such as product protection, sterility, usability, and regulatory requirements.
• Collaborate with cross-functional teams, including R&D, Quality, Regulatory Affairs, and Manufacturing, to define packaging requirements and specifications for new and existing products.
• Utilize CAD software and other tools to create prototypes, conduct feasibility studies, and optimize packaging designs for performance and cost-effectiveness.
2. Regulatory Compliance:
• Ensure packaging designs and processes comply with relevant regulatory standards and guidelines, such as FDA regulations, ISO standards, and European directives.
• Support regulatory submissions by providing comprehensive documentation and technical expertise related to packaging design, validation, and risk management.
3. Quality Assurance and Control:
• Establish and maintain robust quality assurance processes for packaging materials and processes, including supplier qualification, incoming inspection, and non-conformance management.
• Conduct risk assessments and implement mitigation strategies to minimize packaging-related risks throughout the product lifecycle.
4. Continuous Improvement:
• Identify opportunities for process optimization, cost reduction, and performance enhancement within the packaging supply chain.
• Drive continuous improvement initiatives, leveraging best practices, emerging technologies, and industry trends to enhance packaging efficiency, sustainability, and innovation.
5. Cross-Functional Collaboration:
• Collaborate closely with internal stakeholders and external partners, including packaging suppliers, contract manufacturers, and regulatory authorities, to achieve shared objectives and resolve technical challenges.
• Provide technical guidance and mentorship to junior packaging engineers, fostering a culture of excellence and continuous learning within the organization.

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, or a related field. Advanced degree (e.g., MS or PhD) preferred.
• 15+ years of experience in packaging engineering within the medical device or pharmaceutical industry, with a focus on sterile barrier packaging and regulatory compliance.
• Proven track record of successfully leading packaging design and development projects from concept to commercialization.
• Strong understanding of packaging materials, sterilization methods, and packaging validation principles.
• In-depth knowledge of relevant regulatory requirements, including FDA QSR, ISO 11607, and EU MDR.
• Proficiency in CAD software (e.g., SolidWorks) and packaging design tools.
• Excellent communication skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.
• Demonstrated leadership abilities, with experience mentoring junior engineers and driving continuous improvement initiatives.