Job Summary:
Role : QE with Medical Testing
Location : Mounds View Minnesota

Job Description:

FRESHER WITH BIOMEDICAL ENGINEERING BACKGROUND CAN APPLY

• Prior medical device manufacturing background and experience required, coordinates with functional manager / SME to create CO and follow through same for closure .
• Ability to review Design Validation /Specifications /documents /Drawings / Details Data collection in EU MDD / MDR Tech files
• Hazard Analysis / Component Design FMEA / review /verification / Updates
• Experience in Specification development, Agile, Documentum or any document management system
• Experience in Process FMEA/ Risk management CAPA and RCA and provide inputs to Design team.
• Validation documentation against production processes and systems in compliance to internal and external requirements utilizing well developed technical and regulatory skills.
• Proven ability of working in a cross-functional team environment. Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development, QA, etc. as necessary.
• Communicate significant issues or developments identified during production, validation and qualification activities.
• Knowledge on ISO 13485/Part 820 / ISO 14971 and prior Medtronic experience will be preferred.

Must have Skills:
a) Specification Development
b) Test Method Development and Validation
c) Design Verification and Validation
e) Design Input / Design Output Matrix
f) Change Management Process

Nice to Have Skills:
a) Experience with or Exposure to implantable / Tissue or Mechanical Heart Valves