Senior Mechanical Engineer
2 weeks ago
Lonza is a global leader in life sciences, dedicated to improving lives through scientific innovation. We are seeking a talented and driven Senior Mechanical Engineer to join our team in Kingston, ON.
In this role, you will play a crucial part in driving continuous improvements for our cutting-edge Cocoon product line, an automated and scalable cell therapy manufacturing platform. The Cocoon is revolutionizing the field of cell therapy by enabling the production of various treatments for oncology, regenerative medicine, and tissue engineering.
Your Responsibilities:
- Enhance product quality, reliability, manufacturing efficiency, and production yields through innovative design modifications.
- Investigate product complaints and non-conformances, conduct thorough root cause analysis of failures, and propose effective corrective actions.
- Review existing product designs, identify areas for improvement, and implement enhancements to optimize performance and reliability.
- Lead collaborative design updates and implementations of corrective actions within a cross-functional team, ensuring seamless integration across departments.
- Develop strategies for verifying the effectiveness of corrective designs and actively participate in verification activities.
- Generate comprehensive technical documentation, including investigative reports, conceptual designs, mechanical drawings, and technical reports, adhering to ISO 13485 Quality Management System standards.
- Apply a risk-based approach to product design activities, utilizing xFMEA methodology to identify and mitigate potential risks.
Your Qualifications:
- Bachelor's degree in Engineering (Systems, Mechanical, Biomedical, or related field); Master's degree preferred.
- Minimum of 7 years of experience leading product design within a regulated industry, specifically medical devices or product design/manufacture.
- In-depth knowledge of manufacturing processes, including machining, injection molding, and 3D printing.
- Extensive understanding of CAD systems, with proficiency in SolidWorks preferred.
- Proven experience in Design for Manufacturing (DFM) and Design for Assembly (DFA).
- Demonstrated ability to troubleshoot complex issues and implement effective solutions.
- Highly organized and detail-oriented individual with hands-on mechanical aptitude, including the ability to utilize common shop tools and measurement equipment.
- Experience leading technical projects within cross-functional teams (Quality, Design Transfer, and Manufacturing).
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