Senior Packaging Engineer - Bracco Medical Technologies
Eden Prairie, MN 55344
About the Job
As a Senior Packaging Engineer, you will play a key role in the design and development of packaging solutions for our disposable medical devices and capital equipment. You will be a key contributor/leader on cross-functional teams, tasked with providing technical guidance, and ensuring our products meet customer and regulatory requirements. This role is expected to provide technical and functional leadership/supervision as required as the organization grows.
Primary Duties and Responsibilities:
- Design, develop and maintain sterile packaging systems for disposable medical devices and capital equipment. (Corrugate, films, Tyvek, sterile pouches/trays, coiling/catheter restraint systems, clips/tape/mfg. packaging fixtures)
- Design, develop and maintain non-sterile packaging systems for medical device hardware. (Corrugate, foam, trays, pallets, etc.)
- Ensure packaging meets sterilization requirements and maintains product integrity.
- Conduct material selection and testing for packaging components
- Generate protocols, test reports, and engineering adoptions and maintenance of test documentation per approved documentation system per quality standards
- Create Bill of Materials and generate Engineering Change Orders in support of new products and various revisions or maintenance.
- Provide supporting packaging documentation to Regulatory and Quality for submissions and audits.
- Optimize packaging for cost-effectiveness and sustainability
- Support product design changes to develop and improve existing products that affect existing packaging
- Support packaging labeling changes
- Collaborate with cross-functional teams (R&D, Manufacturing, Quality, Regulatory)
- Manage packaging validation processes and documentation.
- Effective collaboration with outside testing services and test labs.
- Ensure correct processes, work instructions, test methods within PDP and Design Control.
- Stay current with industry regulations and packaging technologies (ISTA, ASTM, ISO, etc).
Required Skills
Minimum
- Bachelor's degree in Packaging Engineering, Materials Science, Mechanical Engineering, Manufacturing Engineering, or related field
- 3+ years of experience in medical device packaging
- 5+ years of experience in medical device industry
- Knowledge of sterilization processes and their impact on packaging
- Familiarity with FDA, ISO, and other relevant regulatory standards
- Basic Knowledge of ISO 11607, ISTA, and ASTM Test standards associated with Medical Device Packaging
- Experience with Tyvek, corrugate, films, HIPS trays and other medical-grade packaging materials
- Strong analytical and problem-solving skills (root cause analysis techniques)
- Excellent communication and teamwork abilities
- Proven project management skills
- Experience with coordinating services to outside testing vendors
- Self-starter with strong initiative and personal accountability
Preferred:
- Experienced in the design of experiments, data analysis, statistical methods and presentation of results
- Proven history or packaging design changes improving reliability and/or COGS
Required Experience
Source : Bracco Medical Technologies
