Product Development Engineer

4 weeks ago


Kingston, Ontario, Canada Lonza Full time
Product Development Engineer

Lonza is a global leader in life sciences, operating across three continents. We're seeking a Product Development Engineer to join our team in Kingston, ON, where we have cutting-edge technology like the Cocoon. This automated, scalable, and functionally closed-process cell therapy manufacturing platform is used to manufacture multiple types of cell therapy with applications in oncology, regenerative medicine, and tissue engineering.

Key Responsibilities:
  • Improve product quality and reliability, manufacturing efficiency, and production yields through product design modification.
  • Investigate product complaints and non-conformances, perform root cause analysis of failures, and propose corrective actions in a timely fashion.
  • Review existing product designs, identify weaknesses, propose, and implement improvements.
  • Lead collaborative and complex design updates and implementations of corrective actions and backlog features related to product design within a cross-functional team.
  • Create strategy for the verification of corrective designs and participate in verification activities.
  • Generate and review technical documentation, including investigative pursuits, conceptual design, mechanical drawings, and technical reports, within a ISO 13485 Quality Management System.
  • Apply a risk-based approach to product design activities using xFMEA methodology.
Requirements:
  • Bachelor's degree in an Engineering discipline, such as Systems, Mechanical, Biomedical, or similar path of study; Master's degree preferred.
  • Minimum of 5 years of experience leading product design in a regulated industry, with medical device or product design/manufacture field required.
  • Must have an in-depth knowledge of manufacturing processes, including machining, injection molding, and 3D printing.
  • Extensive understanding of CAD systems, preferably SolidWorks.
  • Design experience with a focus on Design for Manufacturing and Design for Assembly required.
  • Must be able to demonstrate troubleshooting and problem-solving skills.
  • Must be organized and detail-oriented, with hands-on mechanical aptitude, including ability to use common shop tools and measurement equipment.
  • Experience with technical leadership for projects with cross-functional teams (Quality, Design Transfer, and Manufacturing).

Lonza is an equal opportunity employer. We respect and protect our people and our environment. Our success is not just about achieving business results, but also about doing so ethically. We offer the satisfaction that comes with improving lives all around the world and making a meaningful difference.



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