MILLENNIUMSOFT
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
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).
- Review existing product hazards and define the sequence of events for each
- Identify and document new hazards and risks control measures for medical device products
- Maintain accurate risk management artifacts
- Apply knowledge and understanding of ISO 14971
- Participate in product development and design reviews to identify potential risks and provide input for risk mitigation.
- Knowledge of risk assessment methodologies and tools.
- Strong analytical skills and attention to detail.
- Excellent communication skills
- Bachelor's degree in computer science, healthcare, or related field
- 3-5 years of experience in Risk Management, preferably in a regulated industry