A large, global medical device company in Irvine has an oportunity for a R&D Sustaining Engineer. Job Description:
We are looking for a strong engineer with 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 Edwards' procedures. This R&D Sustaining Engineer II will be primary involved in activities associated with the implementation of the EU Medical Device Regulation (MDR) Program.
· 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 support regulatory submissions, clinical trials, and ensure compliance to design control requirements 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 62366 and Human Factors engineering for the legacy products. This would include usability engineering plan, review of and evaluation of historical data and summative evaluation plan.
· Ensures compliance with all Federal, State, local and company regulations, policies and procedures.
· Performs other quality-related duties as assigned by management
· 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 Medical Device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971; and other applicable regulatory requirements)
· Strong critical thinking skills, and ability in handling detailed information/data skills.
· Ability to recognize problems and take corrective measures
· Demonstrated experience prioritizing conflicting demands in a fast paced environment
· Critical thinking, strong problem solving, influencing and negotiation skills
· Ability to work well independently and in a team setting
· Experience working in a dynamic team environment is preferred.
· Ability to manage competing priorities in a fast paced environment.
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in
3 years medical device experience, must have risk management and design control experience.
• Strong critical thinking skills, and ability in handling detailed information/data skills.
• Ability to recognize problems and take corrective measures
• Demonstrated experience prioritizing conflicting demands in a fast paced environment
• Critical thinking, strong problem solving, influencing and negotiation skills
• Ability to work well independently and in a team setting
• Experience working in a dynamic team environment is preferred.
• Ability to manage competing priorities in a fast paced environment.
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