Sandi Mar
Technical Product Manager at Q Bio- Claim this Profile
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Bio
Credentials
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Engineer-In-Training
NCEES
Experience
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Q Bio
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United States
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Biotechnology
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1 - 100 Employee
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Technical Product Manager
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Jan 2021 - Present
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Neuralink
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United States
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Biotechnology Research
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200 - 300 Employee
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Regulatory Engineer
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Jan 2019 - Dec 2020
-Lead writer of regulatory submissions for the FDA including informational meeting, pre-submission (Q-Subs), and Breakthrough Device submissions. -Write and conduct testing plans for Class III neurological surgical robotics and Class III neural implant prototypes (AIMD, ISO 14708) in medical electrical equipment safety (IEC 60601) and biocompatibility (ISO 10993) within a risk analysis environment (ISO 14971). • Lead the verification and validation efforts of sterilization, packaging… Show more -Lead writer of regulatory submissions for the FDA including informational meeting, pre-submission (Q-Subs), and Breakthrough Device submissions. -Write and conduct testing plans for Class III neurological surgical robotics and Class III neural implant prototypes (AIMD, ISO 14708) in medical electrical equipment safety (IEC 60601) and biocompatibility (ISO 10993) within a risk analysis environment (ISO 14971). • Lead the verification and validation efforts of sterilization, packaging, labeling, and software for the surgical robot and related consumables. • Lead research on and facilitate engagement of international medical device regulatory bodies and clinical trial sites. Develop strategic engagement plans for interacting with domestic and abroad regulatory bodies. • Write manufacturing SOPs and quality management documents. Developed a QMS system according to ISO 13485 and 21 CFR 820 (cGMP) requirements.
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Buyer
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May 2018 - Jun 2019
-Wrote and processed over 5000 purchase orders for hardware, electronics, and software engineering R&D projects. -Managed over 75 vendor relationships across manufacturing, biotechnology, medical, and electronics industries -System administrator for purchasing software. Ensured smooth rollout of new purchasing software to over 80+ employees over 4 locations.
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Junior Laboratory and Facilities Manager
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Jan 2018 - Jun 2018
-Established Neuralink's shipping and receiving department, processed all inbound and outbound packages, and assisted with rigging operations for movement of large equipment including lasers, optical tables, and robots -Built and maintained asset management system for office and laboratories -Organized and stocked laboratory inventory spaces -Miscellaneous office management tasks
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UC Davis Energy Conservation Office
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Davis, California
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Green Building Assistant
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May 2016 - Jun 2017
-Wrote and submit forms for Leadership in Energy and Environmental Design (LEED), EBOM program at UC Davis -Supported sustainability initiatives by analyzing campus-wide data sets of water quality and consumption, purchasing records, land and space usage, etc. for cost-saving and energy saving opportunities Notable Achievements: -Achieved Gold Level accreditation for Plants and Environmental Sciences building -Completed and submitted Master Site (overall campus LEED… Show more -Wrote and submit forms for Leadership in Energy and Environmental Design (LEED), EBOM program at UC Davis -Supported sustainability initiatives by analyzing campus-wide data sets of water quality and consumption, purchasing records, land and space usage, etc. for cost-saving and energy saving opportunities Notable Achievements: -Achieved Gold Level accreditation for Plants and Environmental Sciences building -Completed and submitted Master Site (overall campus LEED certification) for UC Davis campus as a solo project -Collaborated with campus managers to achieve and continue sustainability standards, facilitating easier future certification process https://www.usgbc.org/projects/uc-davis-plant-environmental-sciences-0?view=overview Show less -Wrote and submit forms for Leadership in Energy and Environmental Design (LEED), EBOM program at UC Davis -Supported sustainability initiatives by analyzing campus-wide data sets of water quality and consumption, purchasing records, land and space usage, etc. for cost-saving and energy saving opportunities Notable Achievements: -Achieved Gold Level accreditation for Plants and Environmental Sciences building -Completed and submitted Master Site (overall campus LEED… Show more -Wrote and submit forms for Leadership in Energy and Environmental Design (LEED), EBOM program at UC Davis -Supported sustainability initiatives by analyzing campus-wide data sets of water quality and consumption, purchasing records, land and space usage, etc. for cost-saving and energy saving opportunities Notable Achievements: -Achieved Gold Level accreditation for Plants and Environmental Sciences building -Completed and submitted Master Site (overall campus LEED certification) for UC Davis campus as a solo project -Collaborated with campus managers to achieve and continue sustainability standards, facilitating easier future certification process https://www.usgbc.org/projects/uc-davis-plant-environmental-sciences-0?view=overview Show less
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San Mateo County-Human Services Agency
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Belmont, California
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Information Technology Intern
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Jun 2015 - Sep 2015
-Designed and implemented 360° views of 7 HSA office locations on Google PhotoSpheres for public virtual navigation -Compiled data from over 3,000 internal help desk tickets and reported on the efficiency, workload, and results -Created and maintained databases of confidential client, employee, and hardware information - Installed new software packages and conference calling units at six offsite locations -Designed and implemented 360° views of 7 HSA office locations on Google PhotoSpheres for public virtual navigation -Compiled data from over 3,000 internal help desk tickets and reported on the efficiency, workload, and results -Created and maintained databases of confidential client, employee, and hardware information - Installed new software packages and conference calling units at six offsite locations
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UC Davis Orientation Business Office
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Davis, California
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Desk Assistant
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Feb 2014 - Sep 2014
-Answered questions and mitigated conflicts in person from clients of all backgrounds at UC Davis Orientation -Effectively handled over 50 phone calls and emails daily -Developed and maintained log of common questions and answers for training and use at front desk -Recorded and produced creative video for final banquet -Answered questions and mitigated conflicts in person from clients of all backgrounds at UC Davis Orientation -Effectively handled over 50 phone calls and emails daily -Developed and maintained log of common questions and answers for training and use at front desk -Recorded and produced creative video for final banquet
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Education
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University of California, Davis
Bachelor's degree, Biological Systems Engineering