RampD Engineer

• Design verification and validation work
• Risk assessment
• Validation Product Design & Manufacturing
• Testing protocols and reports
• Design history file remediation

Ensure successful completion of all goals on time.

Support the business with audits as needed for he duration of the project

Lead cross functional teams including Manufacturing Engineering Supplier Quality and Operations Quality category management and other team members.

Responsible for developing communicating and documenting project strategies and plans including operations budget and detailed schedule creation and maintenance

Ensure the quality policy/system is planned understood implemented and maintained.

• Ensure Design control requirements are captured properly and are met
• Design verification and validation work
• Draft update and review Risk management files ( RMP/ RMR/PHA/RAC/ FMEA)
• Assist in development of In Process Test Method Validation Protocols Testing reporting
• Drive PFMEA OQ PQ with Manufacturing engg.
• Testing protocols and reports
• Design history file remediation

Performs technical review of DHF files and supports remediation activities to update and transfer existing files to stateoftheart procedures.

Provides analyses for mechanical design and understands interactions between system components.