Associate Engineer Development Consumables (Medtech)

TL;DR

Associate Engineer (Medtech): Designing and developing sterile single-use sensor systems for hemodynamic monitoring and ventilation with an accent on CAD design, material selection, and design transfer. Focus on optimizing product performance, resolving technical production issues, and ensuring compliance with medical regulations such as MDR and 21 CFR 820.

Location: Must be located in the greater Munich or surrounding area (hybrid, 2-3 days on-site in Aschheim-Dornach)

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Manage and support the design, development, and implementation of new single-use medical device sensor systems.
• Drive product care projects and design changes to optimize existing devices and components.
• Coordinate design transfer activities to suppliers and develop manufacturing processes with contract manufacturers.
• Perform development and verification tests in internal labs or with external partners.
• Prepare technical documentation (DHF/DMR), risk analyses, and product specifications according to MDR/21 CFR 820.
• Collaborate with Quality, Regulatory, and Product Management departments.

Requirements

• University degree in Medical, Biomedical, Plastics, or Mechatronic Engineering.
• Must be located in the greater Munich or surrounding area.
• Fluent written and spoken English.
• Knowledge of medical device development processes and manufacturing techniques for consumables.
• Experience with CAD tools, such as SolidWorks.
• Understanding of lean and agile frameworks (Scrum, Kanban).

Nice to have

• First relevant hands-on engineering experience in the medical device industry.
• Competence in sterilization, biocompatibility, or sterile packaging design.
• German language skills.

Culture & Benefits

• 30 paid vacation days per year.
• Possibility of mobile working and workation within the EU.
• Modern workplace equipment and environment.
• Corporate benefits including Business Bike and e-gym Wellpass.
• Individual training and career growth opportunities in a global company.