Lead Mechanical Engineer - Integrated Clinical System (m/f/d)

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.
  

• Degree in Mechanical Engineering, Mechatronics, or a related technical field.

• Minimum of 8 years' experience developing complex, integrated technical products and systems, in a senior or technical leadership role.

• Proven track record of taking physical products from early concept and stakeholder requirements through development, verification, validation, industrialization and series introduction is a must-have.

• Experience in a highly regulated environment, ideally medical devices, diagnostics, pharma/biopharma equipment or another regulated industry is a must-have.

• Experience working within structured product development processes such as the V-model or comparable systems engineering frameworks.

• Strong hands-on mechanical development and CAD expertise, including complex assemblies, integrated systems, detailed design, technical drawings and Bills of Materials.

• Demonstrated ability to solve complex, ambiguous and multidisciplinary engineering challenges through rapid prototyping, testing and iterative development.

• Experience with Design for Manufacturing, Design for Assembly and the successful transfer of products into Manufacturing and Operations.

• Strong product design judgement, with the ability to balance technical performance, usability, aesthetics, manufacturability and overall product quality.

• Experience working across interdisciplinary teams and with external development, manufacturing and technology partners, providing clear technical direction where needed.

• High level of ownership and engineering judgement, combined with a hands-on mindset and a passion for turning innovative concepts into robust, manufacturable products.

• Fluent in English; German is considered an advantage.

• Attractive compensation package, including a competitive base salary and stock options

• Key role in a highly advanced and fast-growing startup company

• Impactful product promoting better understanding and treatment of cancer

• International team, from over 30 different nationalities

• Positive work environment with open communication and a collaborative mindset

• Onsite work at state-of-the-art facilities with home-office opportunities

• Indefinite employment contract

• 30 vacation days

• Flexible working hours

• Annual health budget (Allianz bKV)

• EGYM Wellpass

• Relocation support if needed
  

Join us in making a difference! Submit your application to be considered for this exciting opportunity. 

In your application, we encourage you to highlight the specific products or systems you have worked on, your role in their development, and the development or regulatory environment in which you gained this experience. 

Any questions? Please contact: 

Emilija Stojanovska 

Sr. Talent Acquisition Manager 

mail: careers@nvision-imaging.com