Quality Engineer- Medical Devices

About Us:
CloudCath is redefining infectious disease remote monitoring for millions of patients globally. Our SF based team just closed a Series A funding round and we’re seeking excellent talent to join us leading this exciting mission. Patients rely on implantable catheters to insert/drain fluid from their bodies on a regular basis to address multiple chronic/acute care conditions. Living with and managing this catheter in an outpatient setting without continuous medical supervision can be quite daunting for patients and results in multiple complications, most notable of which is infection origination. Existing standards of care still rely on patients’ compliance with patient dependent non-data driven infection monitoring methods (such as the newspaper test), a state we find out-right unacceptable in 2020 with all this technological advancement at our disposal.

For our initial market - End Stage Renal Disease - the CloudCath device and real-time remote monitoring platform will enable physicians to remotely detect any originating infections within 12 hours from origination, a huge improvement from the 5 day existing standard of care average. We will save more than 3000 US lives annually from certain death (based on existing infection driven hospitalization mortality rates) and $Billions in unnecessary hospitalization. 

Responsibilities:
• Support 13485 certification- perform gap assessments from standards and existing operating procedures; reconcile gaps; participate in audits from 3rd parties. 
• Support manufacturing activities- prepare materials and documentation, support build activities, and review lot history record documentation for accuracy and completeness.
• Perform device design reliability engineering activities including test equipment and fixture design, test setup, data analysis and reporting. 
• Leverage engineering knowledge in conducting complaint evaluations and CAPA investigations to understand potential device failures
• Manage inventory tracking and transfers.
• Complete equipment and fixture qualification and preventive actions
• Apply engineering principles to product design analysis and assessment.

Minimum qualifications:
• Familiar with medical device Quality Management Systems, and Design Controls.
• BS degree in Biomedical Engineering, Mechanical Engineering, or similar.
• Hands-on experience demonstrated in professional or hobbyist projects. 
• Excellent verbal and written communication skills.
• Strong computer skills with MS office applications including Excel
• Experience with statistical data analysis in Excel, Matlab, JMP or Minitab.
• Collaboration in team environments.
• Strong team-player and communication
• Adaptability to a dynamic work environment.

Nice to Have
• Lean six sigma methodology / DFSS / DRMOffice