Product Development Engineer - Mechanical

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 hiring a Product Development Engineer or Mechanical Engineer for our Kingston, ON location where we have cutting edge technology such as the Cocoon. The Cocoon 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).

The Product Development Engineer or Mechanical Engineer will be responsible for driving continuous improvements in the Cocoon product line. This role also ensures the mechanical design for the Cocoon can be sustained for manufacture and distribution within regulated markets, and that field defects are investigated and addressed at the design-level.

Key Responsibilities:

1. Improves product quality and reliability, manufacturing efficiency and production yields through product design modification.
2. Investigates product complaints and non-conformances, performs root cause analysis of failures, and proposes corrective actions in a timely fashion.
3. Reviews existing product designs, identifies weaknesses, proposes and implements improvements.
4. Leads collaborative and complex design updates and implementations of corrective actions and backlog features related to product design within a cross-functional team.
5. Creates strategy for the verification of corrective designs, and participates in verification activities.
6. Generates and reviews technical documentation including investigative pursuits, conceptual design, mechanical drawings, and technical reports, all within an ISO 13485 Quality Management System.
7. Applies a risk-based approach to product design activities using xFMEA methodology.

Key Requirements:

1. Bachelor’s degree in an Engineering discipline such as Systems, Mechanical, Biomedical or similar path of study; Master’s degree preferred.
2. Minimum of 5 years of experience with leading product design in a regulated industry; medical device or product design/manufacture field required.
3. Must have an in-depth knowledge of manufacturing processes: machining, injection molding, 3D printing.
4. Extensive understanding of CAD systems required – preferably SolidWorks.
5. Design experience with a focus on Design for Manufacturing and Design for Assembly required.
6. Must be able to demonstrate troubleshooting and problem-solving skills.
7. Must be organized and detail-oriented, also having hands-on mechanical aptitude, including the ability to use common shop tools and measurement equipment.
8. Experience with technical leadership for projects with cross-functional teams (Quality, Design Transfer and Manufacturing).

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: R61333