Beschreibung
Key Skills: Product Development, Quality
Our client Tier1 IT system integrator are looking for Product Development Engineer to support their project based in Zuchwil, Switzerland.
Job Description:
- To review and remediate the General safety and performance requirements(GSPR) Checklists, Functional Design Requirements, Verification & Validation documentation of Techfiles based on gap analysis with respect to pertinent requirements per applicable EN ISO Standards & MDR/ as identified by client team.
- Transfer data to latest documents templates per the Quality systems and write the missing requirements and map the objective evidences from all available sources.
- Coordinate with various Technical file cross functional teams to make sure that data is aligned across the spectrum.
- But not limited to performing design changes, documentation and reporting of design changes with associated verification and validation data and necessary technical documentation needed to meet the requirements of the medical device directives.
- Support for routing and implementation of the remediated documents in PLM systems.
- Project Management of Technical file update project.
- Support multiple R&D projects. Work with internal R&D teams in the design and development of new patient specific products. Work would include CAD, FEA, GD&T, design of instruments, completion of Risk Assessments, and design validations. Experience with software as a medical device could offset the number of years of experience.
- Engineering experience and demonstrated use of Quality tools/methodologies
- Knowledge/experience on FDA submission, MQMS process - ISO 13485.
- Experience in DHF Audit/Remediation/any Quality engineering related activities.
- Demonstrated knowledge of CAPA process and root cause investigation.
- Demonstrated knowledge of risk management techniques & documentation
- Experience in complaint analysis
- Understanding of data gather and analysis
- Proven record of interpersonal skills to handle client, Result oriented and self-driven
- Good Communication Skills. German proficiency will be added advantages.