Description

Mechanical Engineer needed to perform the following Job duties :

•  Providing support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements.
•  Resolving identified supplier issues and executing the overall project technical file remediation requirements and supporting project deliverables.
•  Working with Suppliers to meet EU MDR requirements and resolve issues with related to Supplier Product information.
• Supporting review and Approval EU MDR Change Projects as applicable and Supplier Quality Functional Impact Assessments as applicable.
•  Review and approving the design documentation including Verification & Validation rationales, risk documents (design and process), standards evaluations, mechanical test protocols and reports.
• Supporting risk management activities including planning, design & clinical risk management DFMEA, production risk management PFMEA, and overall risk summary report.
•  Review and approve verification and validation activities drawing updates, labeling updates and including design impact assessments as required.
•  Applying statistical methods and design/process excellence tools to support design engineering rntinnnIe.s/memn.s a.s requirem.
• Assess MPI and supplier drawings and process information to support project deliverables.
•  Manufacturing Process Information, Production risk management file, Validation protocols and reports and Direct part marking documentation.
• Working with Supply Chain to support EU MDR supplier communications and rollout of EU MDR Supply Chain Workstream activities.
•  Support Review and Approval of supplier Process Validation Protocols and Reports as applicable and update of supplier related Inspection Criteria as applicable.
•  Provide leadership   in all areas of the Quality System,   including,   but   not limited   to   corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.

Bachelor’s Degree Required in Mechanical Engineering or Mechanical Engineering Technology .