Senior Packaging Engineer Job at ACIST Medical Systems, Eden Prairie, MN

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  • ACIST Medical Systems
  • Eden Prairie, MN

Job Description

Job Description

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

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