We are looking for an exceptional Lead Mechanical Engineer (m/f/d) to take technical ownership of the mechanical development and product design of our Clinical Polarizer.
This is a strongly hands-on technical leadership role. You will combine deep mechanical engineering expertise with responsibility for key technical decisions while personally developing, designing and prototyping critical solutions. You will work at the interface of mechanics, fluidics, thermal management, automation and process technology and play a key role in shaping the overall technical direction of the product.
From early concepts and stakeholder requirements through detailed development, verification, industrialization and transfer to manufacturing, you will help turn highly complex technical challenges into robust, manufacturable and clinically outstanding products.
Key Responsibilities:
Take end-to-end technical ownership of the mechanical development and product design, from early concept through industrialization and series introduction.
Act as the technical lead for mechanical and product engineering, driving key decisions on product architecture, design concepts and critical engineering trade-offs.
Stay deeply hands-on by developing critical mechanical solutions, assemblies, and subsystems, including CAD designs, technical drawings, and Bills of Materials.
Translate stakeholder, user and system requirements into robust mechanical architectures and detailed design solutions.
Solve complex and ambiguous technical challenges through rapid ideation, prototyping, testing and iterative development.
Lead technical design reviews and engineering decisions, balancing performance, reliability, usability, manufacturability, cost, regulatory requirements and overall product quality.
Apply Design for Manufacturing and Design for Assembly principles to ensure designs can be reliably industrialized and transferred into production.
Define and maintain mechanical requirements, specifications, design documentation and Design History File contributions within a structured V-model development process.
Define and execute mechanical design verification activities and support system-level verification, validation and regulatory testing.
Work closely with Single-Use Fluid Path Engineering, Process Development, Systems Engineering, Pharma & Regulatory, the Technical Project Manager and external manufacturing and development partners to resolve system-level challenges.
Provide technical direction to internal engineers and external partners and lead mechanical engineering activities during industrialization and production ramp-up.