Votre mission :

With strong technical expertise in process improvement, a deep understanding of quality management systems, and the ability to drive both operational excellence and product reliability, le Sr Process Engineer will:

-Play a dual role in optimizing manufacturing and quality control processes and ensuring product quality throughout the production lifecycle.  

-Act as an expert leader in cross-functional coordination and project management, with no direct hierarchical management responsibilities in the short term

-Work cross-functionally with design, manufacturing, and regulatory teams to develop, monitor, and improve processes that meet stringent quality standards.  

Missions & main duties:

- Process Engineering:

Develop, implement, and optimize manufacturing and quality control processes to improve efficiency, reduce waste, and increase product quality.

Collaborate with cross-functional teams to design and validate new processes and equipment  

Support the manufacturing manager in production data analysis to identify trends, deviations, and opportunities for process improvement.

Support the manufacturing manager in implementing lean manufacturing techniques, Six Sigma methodologies, and other process optimization tools.

Troubleshoot and resolve issues related to production processes, ensuring minimal downtime and maintaining continuous improvement efforts.

- Quality Engineering:

Lead or support cross-functional teams in quality assurance activities, including developing test plans, inspecting processes, and auditing quality systems.

Design and implement control plans, risk assessments (FMEA), and corrective action processes to maintain product quality.

Conduct root cause analysis on non-conformities and implement corrective and preventive actions (CAPA).

- Cross-Functional Collaboration:

Act as a liaison between manufacturing, design, and quality teams to ensure product designs are optimized for manufacturability and quality.

Provide feedback to design engineers to influence product design improvements and ensure alignment with manufacturing capabilities.

Support product development teams in risk management and verification and validation (V&V) activities.

Annual gross salary : 48KEUR - 58KEUR

Votre profil :

Education: Master degree in mechanical, industrial, manufacturing, or related engineering field.
Experience: 5+ years of experience in process engineering and/or quality engineering, preferably in a manufacturing or product development environment.  
Technical Expertise:

Knowledge of process optimization methodologies (Lean, Six Sigma, etc.).

Knowledge in statistical process control (SPC), design of experiments (DOE), and root cause analysis techniques.

Experience with quality management systems (QMS) and regulatory compliance (ISO 9001, ISO 13485, FDA).

Familiarity with risk management tools (FMEA, CAPA) and problem-solving methodologies (5 Whys, Fishbone Diagram).

Expertise with validation of processes and equipment, including IQ/OQ/PQ.
Software Proficiency: Knowledge in statistical software tools like JMP or Minitab, or similar for process simulation and analysis.
Soft Skills: Strong communication and project management skills; the ability to work cross-functionally.
Certifications: Lean Six Sigma Green/Black Belt or CQE (Certified Quality Engineer) certification is a plus.

A propos de Stilla Technologies :

Stilla Technologies is a life sciences instrumentation company whose mission is to improve health by providing researchers and clinicians around the world with high-precision genetic analysis solutions.

Since 2016, Stilla Technologies has provided researchers around the world with the naica® system, a solution that can detect and quantify DNA with unprecedented precision.

The naica® system and our recently launched Nio system supports a wide range of genetic and molecular biology assays, including AAV titering, liquid biopsy tests for cancer research, viral quantification, GMO detection, etc. Overall, the superior performance of the naica® and Nio systems makes them a preferred technology for precision medicine research and therapeutic monitoring.

Stilla advises and supports its clients around the world with a multidisciplinary team, whose expertise extends from micro fluidics and chemistry to molecular biology and computer science. Stilla's talented and multidisciplinary team shares a passion for creating highly innovative products dedicated to life sciences research and clinical diagnostics.