**agap2**
is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.

As a
**consultant**
, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.

We are looking for a
**Manufacturing Engineer**
to support medical device industrialization and production optimization in regulated environments.

**Your Responsibilities**

• Support technology transfer from R&D to Manufacturing

• Lead production line implementation (URS, supplier selection, FAT/SAT)

• Qualify equipment (IQ/OQ/PQ) and validate manufacturing processes

• Ensure compliance with ISO 13485, MDR/FDA and GMP requirements

• Perform risk analysis (Process FMEA), root cause analysis & CAPA

• Optimize processes using SPC, KPIs and Lean Manufacturing tools

• Support ramp-up, pilot builds and routine production

**Your Profile**

• 3+ years in MedTech manufacturing (regulated environment)

• Strong experience in process validation & equipment qualification

• Knowledge of quality systems (ISO 13485, GMP)

• Hands-on mindset, production floor oriented

• Fluent German & English

• EU or Swiss citizenship

**Why join us?**

• Exposure to major Swiss pharmaceutical & medical devices manufacturing sites

• Long-term industrial projects in commercial production

• Strong local support and career development opportunities

• Dynamic, committed team with strong human values

*Only applications from Swiss and EU citizens will be considered. Please note that due to Brexit we are no longer accepting applications from the UK.*