Junior Manufacturing Engineer
Switzerland
Full Time
6 hours ago
No Sponsorship
Key skills
RProject ManagementRisk ManagementCommunicationDecision MakingProblem SolvingCollaboration
About this role
Role Overview
- Identify and resolve complex technical and operational challenges related to the R&D/QE Workstream for Orthopedics
- Working with other stakeholders in Aarau to contribute to overall decision making, cross functional thinking and to progress the overall project
- Define and implement procedures and templates within the R&D/QE environment by keeping products compliant with legislation and allowing products to be maintained in the market place
- Update of all R&D/Quality documentation (e.g. Design History Files, Design Control documents, Verification/Validation documentation, Risk Management files) in line with the General Safety and performance requirements specified within the MDR legislation in line with new product groupings
- Ensure that all product testing data (e.g. Life-Cycle, MRI, biocompatibility) is remediated or developed to MDR standards
- Update existing R&D/Quality processes for maintenance/creation of design history files and other supporting documentation
- Establish new processes for future NPD project initiation taking into account the increased evidence, scrutiny and costs of gaining product registration under the MDR legislation
- Assess design related risks
- Prepares design drawings and acts as a consultant in the preparation of final or modified drawings in line with MDR requirements
- Support and advise other team-members in the R&D/QE Workstream enabling them to work efficient and autonomous
- Support elicitation and procurement of new manufacturing equipment
- Identify and drive continuous improvement initiatives, including cost reduction opportunities
Requirements
- Bachelor’s degree in Mechanical Engineering, Biomechanical Engineering, Engineering Mechanics or related engineering field
- 3-5 years’ experience in Medical devices with project management experience
- Ability to work effectively in a cross-functional team environment
- CAD (NX)
- Strong written and verbal communication and technical writing skills (German and English)
- Analytical approach to problem solving
- Must have strong documentation skills with attention to detail.
Benefits
- Professional development opportunities
- Company culture of care, collaboration and courage