About This Role

iRhythm Technologies, Inc. is seeking a highly skilled and experienced Senior Quality Engineer to join our vibrant team. This role is for a Risk Management expert, who would be assisting in the development, maintenance and continuous improvement of the global medical device risk management strategies and procedures for iRhythm products and processes. This individual will play a key role in achieving products of the highest quality and maintain regulatory compliance to medical device risk management standards and regulations, including the EU MDR requirements.

This is a hybrid role and will require an in-office presence 2 days/week in our Cypress, CA location. Relocation assistance is not being offered.

Responsibilities:

• Your quality or clinical background and expertise in ISO 14971 will be utilized to strengthen the Organizational understanding and importance of applying proper Risk Management processes and techniques.
• You will lead Risk Management activities within product development (Design and Use), manufacturing processes (PFMEAs), and the post-market surveillance phase.
• You will provide quality oversight to project teams in terms of the Risk Management System, including post-market information of similar products' feedback into the new product development cycle.
• Your knowledge will be utilized to develop and maintain Post-Market Health Hazard/Risk Evaluations across all products.
• You will lead activities to maintain a closed-loop Risk Management process that incorporates information obtained from post-market surveillance into new product development, process improvements, and clinical evaluation reports.
• You will interface with iRhythm's clinical team, including Medical Directors as necessary, to standardize Risk Management approach across product design, manufacturing, and post-market surveillance processes.
• You will represent Risk Management processes and documents during internal and external audits.
• You will keep abreast of emerging regulatory and industry trends regarding risk management and act as the risk coach and trainer within iRhythm.

Required Qualifications:

• Bachelor's Degree in science, engineering, or healthcare related field.
• Minimum of 5 years of experience in Quality, Regulatory, or Clinical related role.
• Experience with Risk Management standards such as ISO 14971 and Risk Management tools, methodologies, and processes including use of a variety of accepted methods.
• Working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDR requirements.
• Must build rapport across functional teams within the organization and collaborate on risk management activities
• Attention to detail and timeliness are critical
• Excellent communication (verbal and written) and interpersonal skills required
• Direct exposure to FDA inspections and Notified Body audits preferred
• Clinical experience or background preferred

What's In It For You

This is a regular full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurances (all of which start on your first day), health savings account employer contributions (when enrolled in high deductible medical plan), cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts), travel reimbursement for medical care, noncontributory basic life insurance & short/ long term disability. Additionally, we offer:

• emotional health support for you and your loved ones
• legal / financial / identity theft/ pet and child referral assistance
• paid parental leave, paid holidays, travel assistance for personal trips and PTO!

iRhythm also provides additional benefits including 401(k) (with company match), an Employee Stock Purchase Plan, pet insurance discount, unlimited amount of LinkedIn Learning classes and so much more!

FLSA Status: Exempt

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