Mechanical Engineer for new medical device development

• Responsibility for assigned work packages within a matrix-organized project structure in collaboration with external development partners

• Participation in the definition, estimation, planning, and implementation of work packages in a sprint-based agile environment, in close coordination with product owners, scrum masters, architects, and developers

• Execution of all phases of mechanical development from feasibility studies, design reviews, unit testing, root cause analysis, bug fixing, through to maintenance

• Definition and execution of detailed engineering analyses such as Computational Fluid Dynamics (CFD), Finite Element Analysis (FEA), Failure Modes and Effects Analysis (FMEA), tolerance analyses, and simulations

• Technical mentoring and support of junior engineers

• Execution of technical reviews with stakeholders from R&D, Operations, and Customer Support

• Management of mission-critical tasks and complex technical solution development

• Collection and documentation of unit specifications in close cooperation with stakeholders, leading to implementation

Qualifications:

• Bachelor’s degree or higher in Mechanical Engineering

• Minimum 8 years of relevant professional experience in a regulated industry, preferably in medical technology (candidates without MedTech industry experience can also be considered, but experience in a highly regulated environment such as aerospace, automotive, etc. is important)

• Extensive experience in material selection and design for manufacturing, serviceability, and sustainability

• Advanced expertise in injection molding design and plastic technologies, ideally for cost-optimized, high-volume production of functional consumables

• Solid background in the development of complex medical mechatronic systems, including components such as pumps, valves, actuators, sensors, temperature control elements, etc.

• Expert knowledge in CAD for mechanical design, particularly SolidWorks (mandatory) combined with SAP; compliant with ISO 8015 / Geometrical Product Specifications (GPS) for 2D drawings and 3D models

• Methodical and systematic approach across all development phases, with a strong understanding of physics and engineering fundamentals

• Proven ability to work successfully in multidisciplinary teams within regulated environments

• Willingness to work in a fully agile, transparent structure

• Strong project leadership skills, capable of independently managing external development partners and suppliers

• Fluency in English is required; comprehension of German (listening and reading) is a plus