What are the responsibilities and job description for the Packaging Development Engineer position at NovintiX?
Company Description
NovintiX is a leader in engineering services, dedicated to creating innovative products, services, and solutions that transform lives and push the boundaries of technology. Serving diverse industries such as Medical Devices, Aerospace, Automotive, and Consumer Electronics, NovintiX specializes in Product Engineering, Supply Chain & Manufacturing, and Digital Solutions, among other areas. With a mission to empower growth and excellence, the company fosters an environment of innovation for both its customers and employees. NovintiX is committed to sustainability, quality, and making a meaningful impact through its solutions.
Role Overview:
Lead packaging design, development, and supplier management projects for medical device products. Drive end-to-end packaging solutions from concept through validation, ensuring compliance with regulatory standards and manufacturing requirements.
Key Responsibilities:
- Manage packaging design and development projects for medical devices from concept to commercialization
- Lead cross-functional teams in developing sterile barrier systems, primary/secondary packaging solutions
- Oversee supplier selection, qualification, and ongoing management of packaging component vendors
- Develop project timelines, budgets, and risk management plans for packaging initiatives
- Conduct packaging validation activities (IQ/OQ/PQ) and ensure regulatory compliance (ISO 11607, ASTM standards)
- Collaborate with R&D, Quality, Manufacturing, and Regulatory teams on packaging specifications
- Manage change control processes and implement SOP/process updates for packaging operations
- Drive continuous improvement in packaging processes, materials, and cost optimization
Required Qualifications:
- 10 years of project management experience in medical device manufacturing or related industry
- Proven experience in medical device packaging design and development
- Bachelor's degree in Engineering, Packaging Engineering, or related technical field
- Hands-on experience managing packaging suppliers and vendor relationships
- Strong understanding of ISO 11607, ISO 13485 and medical device packaging regulations
Must-Have Technical Skills:
- Project Management: Full lifecycle management of packaging development projects
- Packaging Design: Sterile barrier systems, primary/secondary/tertiary packaging for medical devices
- Supplier Management: Vendor selection, qualification, and performance management
- Regulatory Knowledge: ISO 11607, ASTM packaging standards, FDA 21 CFR Part 820
- Change Management: SOP/process updates, change control documentation
Preferred Qualifications:
- Experience with orthopedic medical devices
- CAD software proficiency (SolidWorks, AutoCAD) for packaging design
- Six Sigma Green/Black Belt certification
- Knowledge of sustainable packaging materials and design for manufacturability