R&D Packaging Specialist

2 months ago

Mississauga, Ontario, Canada Boston Scientific Gruppe Full time

About the Role

We are seeking a highly skilled Senior R&D Engineer to join our dynamic R&D Packaging and Sellable Product team at Boston Scientific Gruppe. As a Senior R&D Engineer, you will be responsible for leading the design, development, and implementation of packaging solutions for our products, working closely with cross-functional teams, including Marketing, Regulatory, and Supply Chain.

Key Responsibilities

  • Lead various packaging design projects in support of new product development and continuous improvement initiatives.
  • Develop packaging specifications based on collected Voice of Customer (VOCs), business requirements, and regulatory standards.
  • Utilize CAD software and prototyping techniques to create and iterate packaging designs.
  • Evaluate new packaging designs through testing to ensure compliance with performance metrics.
  • Create Design History File (DHF) and Device Master Record (DMR) documentation to capture design control and risk management activities for packaging development.
  • Collaborate cross-functionally with various departments to develop strategies for streamlining regulatory approval and commercialization of products in various jurisdictions.
  • Independently plan and coordinate activities to meet project timelines and deliverables.
  • Provide technical leadership and coaching for junior engineers on the team.
  • Support investigations, as needed, for packaging-related non-conformances and Corrective and Preventative Actions (CAPAs).

Requirements

  • Bachelor's degree in Packaging Engineering, Mechanical Engineering, or a related field.
  • 5+ years of experience in packaging engineering, preferably within the medical device industry.
  • Proficiency in CAD software (e.g., SolidWorks) and packaging design tools.
  • Strong knowledge of packaging materials, processes, and manufacturing methods.
  • Familiarity with packaging testing standards (e.g., ISO 11607).
  • Familiarity with the design control process per ISO 13485.
  • Excellent project management skills with the ability to prioritize and manage multiple projects simultaneously.

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