Position                            : Risk Analyst

Location                           : San Diego, CA

Duration                          : 12 Months

Total Hours/week            : 40.00

1^st 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 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.

Skills and Competencies

• Knowledge of risk assessment methodologies and tools.
• Strong analytical skills and attention to detail.
• Excellent communication skills

Qualifications and Experience

• Bachelor’s degree in computer science, healthcare, or related field
• 3-5 years of experience in Risk Management, preferably in a regulated industry