What are the responsibilities and job description for the Senior Packaging Engineer position at Bracco Medical Technologies?
At Bracco Medical Technologies, every employee has an impact on our Mission to empower lifesaving
decisions. We create medical devices that give healthcare providers the
insights they need to confidently and safely diagnose patients. Our unique line
of products includes Intravascular Ultrasound (IVUS), Fractional Flow Reserve
(FFR), Cardiovascular Imaging contrast delivery (CVi), and CT and MRI contrast
delivery systems.
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).
Minimum
- Bachelor's degree in Packaging Engineering, Materials Science, Mechanical Engineering, Manufacturing Engineering, or related field
- 3 years' [ST1] experience in medical device packaging
- 5 years' 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
ACIST Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
