Sr Systems Engineer (Plastics)- Kingston ON

Canada, Kingston

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza is seeking extraordinary engineer professionals for a Sr Systems Engineer role at our Kingston, ON location.  You will be responsible for driving continuous improvements in the Cocoon® product line, specifically - the plastic disposables for the Cocoon® Platform.   The Cocoon® Platform is an automated, scalable, and functionally closed-process cell therapy manufacturing platform. The Cocoon® is used to manufacture multiple types of cell therapy with applications in oncology (i.e. CAR-T), regenerative medicine (i.e. HSCs, MSCs) and tissue engineering (i.e. orthopedics). 

You will be responsible to ensure the mechanical design for the Cocoon Cassette (single-use plastic assembly) can be sustained for manufacture and distribution within regulated markets, and that field defects are investigated and addressed at the design-level. 

https://pharma.lonza.com/technologies-products/cocoon-platform

Key responsibilities:

  • Improves product quality and reliability, manufacturing efficiency and  production yields through product design modification
  • Takes ownership of the disposable product lines to address opportunities related to performance and vision for the product through connection with the users’ needs as well as design-for-assembly
  • Stewards the Design History File and Device Master Record through thorough documentation of specification updates, design verification, design information, risk assessments, etc.
  • Investigates product complaints and non-conformances, performs root cause analysis of failures, and proposes corrective actions in a timely fashion
  • Reviews existing product designs, identifies weaknesses, proposes and implements improvements
  • Sources parts as required, and manages vendor issues as needed
  • Leads collaborative and complex design updates and implementations of corrective actions and backlog features related to product design within a cross-functional team
  • Creates strategy for the verification of corrective designs, and participates in verification activities
  • Generates and reviews technical documentation including investigative pursuits, conceptual design, mechanical drawings, and technical reports, all within a ISO 13485 Quality Management System
  • Applies a risk-based approach to product design activities using xFMEA methodology

Key requirements:

  • Bachelor’s degree in an engineering discipline such as  Systems, Mechanical, Chemical, Biomedical or similar path of study; Master’s degree a plus
  • PMP and/or PEng a strong plus
  • Experience working in medical device or product design/manufacture field
  • Experience in a technical support/ quality managed environment
  • Development of plastic parts, ideally for disposable medical items and their standards
  • In-depth knowledge of manufacturing processes: machining, injection molding, 3D printing
  • Design experience with a focus on Design for Manufacturing and Design for Assembly
  • Extensive understanding of CAD systems – preferably SolidWorks
  • Navigating complex processes and workflows required in regulated environments
  • Demonstrated troubleshooting and problem solving skills – organized and detail oriented, hands-on
  • Mechanical aptitude, including ability to use common shop tools and measurement equipment
  • Experience working with bioreactor design and/or cell culture, a plus
  • Experience with statistical analysis (ex. Minitab), desired

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 

Reference: R45228
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