Manufacturing Engineer(m/w/x)

Requirements

• Degree in Mechanical, Biomedical, or related engineering
• Biomedical Engineering or Bioengineering Master’s preferred
• Industrial experience in medical device environments
• Experience designing, manufacturing, or prototyping medical devices
• Experience in regulated environments (ISO, FDA)
• Knowledge of Lean Manufacturing and Six Sigma
• Self-motivated, team-oriented, and solution-focused
• Fluent in English, written and spoken
• Fluency in German is a strong plus
• Very good organization and planning skills
• Ability to lead projects with teams
• Effective communication skills
• Good skills in MS Office

Tasks

• Design and implement new medical device products
• Develop efficient manufacturing processes and test methods
• Execute design changes for specification remediation projects
• Conduct engineering studies for process improvements
• Identify and implement cost-saving opportunities
• Lead and coordinate validation and improvement projects
• Collaborate with cross-functional teams on continuous improvement
• Comply with safety regulations and promote best practices
• Specify and revise manufacturing documentation for components
• Lead OpEx, Lean, and Six Sigma initiatives
• Provide technical support to R&D, QE, QA, and production
• Perform Design of Experiments and process capability analyses
• Conduct root cause analyses using 5 Whys and Ishikawa
• Analyze data and interpret results using Minitab
• Write technical reports and statistical summaries
• Support production lines and transfer new products
• Execute and document DVVs and process validations
• Support Test Method Validations
• Apply basic tooling, design, and drafting knowledge
• Monitor processes and collect performance data
• Document activities according to regulatory and internal standards

Work Experience

Education

Languages

Tools & Technologies