Contract position: Global medical device manufacturer has an immediate need in Round Lake IL for a Medical Device Risk-Subject Matter Expert. We are looking for a candidate that has deep experience/expertise in Product Risk Management, particularly in the Medical Device space. This is a contract position expected to last 6 months, could be longer based on performance, possible temp to hire. Great Contractor Benefits! Apply Now! Will hire ASAP!Responsibilities for the Principal Engineer
Requirements for the Principal Engineer
- Lead teams in Risk Management Planning, hazards & harms analysis, risk estimation, creation/derivation of FMEA/FTAs, and defining risk mitigation strategies.
- Provide technical leadership in execution and improvements for Product Risk Management process activities
- Demonstrated ability to lead technical teams in creation/remediation of Risk process assets (Hazards Analysis, FMEAs, FTAs, Risk Reports, etc.)
- Determine the Define/Measure/Analyze elements of the investigation
- Confirm corrections/containment identified based on the investigation results
- Develop strategic improvement plan for the Design Control Quality Management System per 21 CFR Part 820, ISO 13485 and CMDR
- Bachelor's Degree in Engineering or Science is preferred.
- 8+ years of hands-on experience in Design Control & Risk Management, and fluent in full life-cycle product development methods/activities within the medical device, bio or pharma industry
- Must possess strong engineering knowledge and experience in Electromechanical disciplines and design principles, particularly Medical Devices (e.g., Infusion Pumps)
- Deep experience/expertise in Risk Management, particularly in the Medical Device space; demonstrated ability to lead technical teams in creation of Risk process assets
- Expertise and fluency in Excel, DOORs, WindChill and/or other Requirements Management & Risk tools.
- Required: e.g., ISO 13485*, ISO 14971*, IEC 61025
- Paid Vacation
- Health Insurance, and more...
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.