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Medical Device Packaging Engineer

Tekaccel Inc
OH Full Time
POSTED ON 4/6/2025
AVAILABLE BEFORE 5/4/2025

Job Title : Medical Device Packaging Engineer

Location : Cincinnati, OH (Onsite)

Experience : 4-6 Years

Role Overview :

We are seeking a skilled and experienced Medical Device Packaging Engineer to support packaging system development, validation, and process optimization for sterile and non-sterile medical device products. The ideal candidate will collaborate with cross-functional teams and ensure compliance with industry standards and regulations.

Key Responsibilities :

  • Packaging Project Support : Design, source, and implement packaging systems for medical devices, ensuring alignment with project requirements.
  • Cross-Functional Collaboration : Work closely with teams on New Product Development and commercial changes, contributing to packaging system development.
  • Process Development : Assist in selecting manufacturing equipment and conducting IQ, OQ, PQ activities for process development.
  • Material & Technology Evaluation : Assess and validate new packaging and labeling technologies, supporting line trials and validation activities.
  • Risk Management : Perform risk assessments and ensure compliance with quality management system design controls.
  • Verification & Validation : Support Verification and Validation (V&V) activities, collaborating with external testing facilities.
  • Technical Evaluations : Conduct engineering studies and testing to justify the use of selected materials and packaging components.

Essential Skills :

  • Familiarity with Good Manufacturing Practices (GMPs) and ISO regulations (ISO11607-1 / -2 and ISO13485)
  • Expertise in material and packaging test methods (ASTM, ISTA) and sterilization processes
  • Proficiency in packaging design software (Artios CAD, CAPE Pack, TOPS)
  • Strong project management skills and the ability to handle multiple projects simultaneously
  • Capability to work independently and collaborate effectively with cross-functional teams
  • Desirable Skills :

  • Knowledge of risk management and quality assurance processes
  • Experience in Verification and Validation (V&V) activities
  • Strong problem-solving skills with a focus on process optimization
  • Competencies :

  • Life Sciences : Medical Device Packaging Engineering
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