Position : Risk Analyst
Location : San Diego, CA
Duration : 12 Months
Total Hours / week : 40.00
1st Shift
Client : Medical Devices Company
Job Category : Engineering / Technical
Level of Experience : Mid-Level
Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)
Job Description : Summary
- The Risk Analyst is responsible for identifying and assessing potential risks associated with the use of a medical device, and for developing strategies to manage those risks.
- They bring strong product knowledge and collaborate with cross functional resources to define sequences of events which may lead to harm, thus supporting the overall risk assessment.
- They will support the creation and maintenance of compliance artifacts to be stored in the DHF (Design History File).
Responsibilities
Review existing product hazards and define the sequence of events for eachIdentify and document new hazards and risks control measures for medical device productsMaintain accurate risk management artifactsApply knowledge and understanding of ISO 14971Participate in product development and design reviews to identify potential risks and provide input for risk mitigation.Skills and Competencies
Knowledge of risk assessment methodologies and tools.Strong analytical skills and attention to detail.Excellent communication skillsQualifications and Experience
Bachelor's degree in computer science, healthcare, or related field3-5 years of experience in Risk Management, preferably in a regulated industry