Role Responsibility: Reporting to the Development & QE Workstream site-lead Aarau for MDR, the role has the responsibility of working in the Development & QE MDR Workstream to plan and execute Development & QE activities to support the remediation of products relative to the European Medical Device Regulations (MDR), ensuring products maintain quality standards, comply with regulatory and compliance standards. Job responsibilities include addressing well defined problems of limited scope and following standard practices and procedures.
This workstream is responsible for ensuring all product related documentation submitted as part of a technical file is remediated to standards required by the MDR legislation. In addition new processes must be established for NPD projects to ensure future MDR compliance – including those within the current project pipeline and future project initiation.
Main Tasks:
Identify and resolve complex technical and operational challenges related to the Development & 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 Development & QE environment by keeping products compliant with legislation and allowing products to be maintained in the market place
Update of all Development & QE 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 relatated 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 Development & QE Workstream enabling them to work efficient and autonomous
Job Requirements:
Bachelor’s degree in Mechanical Engineering, Biomechanical Engineering, Engineering Mechanics or other related engineering field
Ability to work effectively in a cross-functional team environment
CAD (NX)
High learning agility
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.
3-5 years’ experience in Medical devices with project management experience
