Sr Manager, Document Control
Diabetes Youth Families
Senior Post-Market Reliability Engineer, CS
Medtronic
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $106,400 - $159,600 per year
Job Level
Senior
About the role
- Senior Post Market Reliability Engineer supporting the Cardiac Surgery Post Market Quality organization with responsibility for Post Market Surveillance, Risk Management, Shelf-Life testing and complaint investigations associated with all Cardiac Surgery products. Write Issue Impact Assessments (IIAs), excursion memos, and Periodic Safety Update Reports (PSURs); and support Field Corrective Actions (FCAs), Product Hold Orders (PHOs), CAPAs, Complain Investigations, and Shelf-Life testing. Collaborate with other Quality, RPE, Regulatory, and Manufacturing colleagues to ensure product issues, compliance concerns, supplier and manufacturing non-conformities are addressed and cost effective. Understand design and risk implications to changes, collaborate cross-functionally, generate and review DFMEAs, test method validations and test reports in compliance with design control and risk management procedures.
Requirements
- Bachelor’s degree required in engineering or technical discipline Minimum of 4years of technical experience, or advanced degree with a minimum of 2 years technical experience Strong written and verbal communication skills and work cooperatively as part of a team and cross functionally. Ability to manage multiple projects and timelines to execute deliverables in a timely manner. Ability to solve problems and innovate solutions. Quality experience working in a Medical Device Industry. Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS. Familiarity with these regulations: FDA 21 CFR Part 820 cGMP, ISO 13485, ISO 10012, and ISO 17025.
