Contract position: Our client in Irvine is looking for a Senior Engineer to start right away who has solid technical expertise, who enjoys working in a fast paced and rapidly growing environment. The engineer will perform a variety of responsibilities including driving quality system engineering, risk management and usability engineering activities as part of a cross functional team to support regulatory submissions and to ensure compliance with regulatory requirements and clients' procedures. Responsibilities for the R&D Engineer
Requirements for the R&D Engineer
- Provides Quality Engineering expertise in the areas of Design Controls, Risk Management, Statistical Techniques, Quality Assurance/Control, and Regulatory Compliance.
- Provides Quality Engineering support for new expanded indication projects to supportregulatory submissions, clinical trials, and ensure compliance to design controlrequirements by approving design control documentations
- Develop and maintain Risk Management Files according to ISO 14971 for new or legacy products and ensure Risk Management Files are updated per defined schedules and frequencies. This would include risk management reports, hazard analyses, user risk assessments, design risk assessments and process risk assessments
- Supports the Risk Management and Post-Market Surveillance Review meetings to ensure all activities are completed to maintain the risk management file as new information is learned during the product development process or per signals obtained through post-market surveillance programs, as needed
- Assists developing and maintaining Usability Engineering Files according to ISO 6236 6and Human Factors engineering for the legacy products. This would include usability engineering plan, review of and evaluation of historical data and summative evaluation plan.
- Bachelor's degree in engineering and a minimum of three (3) years of experience within the medical device industry, or a combination of medical device and other related regulated environment experience.
- Proven experience working with medical device companies' Risk Management, Design Control and Human Factors Usability Engineering programs and/or processes.
- Knowledge of the Domestic and International regulatory requirements of MedicalDevice regulations (FDA 21 CFR 820, ISO 13485, ISO 14971; and other applicableregulatory requirements)
- Contractor Benefits Available
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.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.