Senior Mechanical Product Engineer
3 weeks ago
Company Overview: Lonza is a prominent global entity in the life sciences sector, operating across multiple continents. Our approach to science is rooted in collaboration, where talented individuals unite to generate innovative solutions that benefit businesses and improve lives.
Position Summary: We are seeking a Senior Product Development Engineer or Mechanical Engineer to enhance our innovative Cocoon Platform, a state-of-the-art automated cell therapy manufacturing system. This role is pivotal in ensuring the mechanical design is optimized for production and distribution in regulated markets.
Key Responsibilities:
- Enhance product quality, reliability, and manufacturing efficiency through strategic design modifications.
- Conduct thorough investigations of product complaints and non-conformances, performing root cause analyses and proposing timely corrective actions.
- Review and refine existing product designs, identifying areas for improvement and implementing effective solutions.
- Lead cross-functional teams in complex design updates and the execution of corrective actions related to product design.
- Develop strategies for verifying design corrections and actively participate in verification processes.
- Create and review comprehensive technical documentation, including investigative reports, conceptual designs, and mechanical drawings, adhering to ISO 13485 standards.
- Utilize a risk-based approach in product design activities, employing xFMEA methodologies.
Qualifications:
- Bachelor's degree in Engineering (Systems, Mechanical, Biomedical, or related field); Master's degree preferred.
- A minimum of 7 years of experience in product design within a regulated industry, specifically in medical devices or product manufacturing.
- In-depth knowledge of manufacturing processes, including machining, injection molding, and 3D printing.
- Extensive experience with CAD systems, particularly SolidWorks.
- Proven design experience focusing on Design for Manufacturing and Design for Assembly principles.
- Strong troubleshooting and problem-solving capabilities.
- Detail-oriented with hands-on mechanical aptitude, including proficiency with common shop tools and measurement equipment.
- Experience in providing technical leadership for projects involving cross-functional teams (Quality, Design Transfer, and Manufacturing).
At Lonza, we are committed to making a positive impact on millions of lives through our products and services. We uphold the highest ethical standards in achieving our business objectives, ensuring that our success is measured not only by results but also by the integrity of our processes.
We value creativity and the challenge of solving complex problems in the life sciences field, offering our employees the satisfaction of making a meaningful difference in the world.
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