Founder And Ceo
CurrentFounder of Medical Device QMS consulting firm. Expertise in SaMD/SiMD and focus on AI.
Oct 2023 - Present
AeroLeads people directory · profile
Ashkon R. Email & Phone Number
Non-BS QMS Advocate. SaMD/SiMD/AI/ML. Medical Device QMS Strategist.
at
EnGenius Solutions LLC
LinkedIn matched
✓ Verified May 2026
2 data sources
Profile completeness 71%
Current company
Role
Non-BS QMS Advocate. SaMD/SiMD/AI/ML. Medical Device QMS Strategist.
Location
Costa Mesa, California, United States
Who is Ashkon R.? Overview
A concise factual answer block for searchers comparing this professional profile.
Quick answer
Ashkon R. is listed as Non-BS QMS Advocate. SaMD/SiMD/AI/ML. Medical Device QMS Strategist. at EnGenius Solutions LLC, based in Costa Mesa, California, United States. AeroLeads shows a matched LinkedIn profile for Ashkon R..
Ashkon R. previously worked as Founder and CEO at Engenius Solutions Llc and Director, Quality Management Systems at Big Health.
Company email context
Email format at EnGenius Solutions LLC
This section adds company-level context without repeating Ashkon R.'s masked contact details.
EnGenius Solutions LLC
Review company-level records connected to Ashkon R. before choosing the right outreach path.
Profile bio
About Ashkon R.
In Numbers:● 40: Largest SaMD Development Team Led● 12 : Years of SaMD/SiMD design and development experience● 9: Commercial FDA Regulated SaMD/SiMD Devices Worked On● 5: Publications and Presentations● 2: Policy-Making EngagementsAshkon is a medical device Quality Management Systems strategist with a focus on software as SaMD or SiMD. His unique background boasts first-hand experience in a variety of roles including product management, development, testing, QMS and regulatory and in a variety of business environments including established medical device companies with high-risk products such as Edwards LifeSciences, established tech companies with best-in-class software practices such as Alphabet's Verily, and a number of VC-backed startups at the forefront of such health tech sectors as digital therapeutics, wearables, and disease management platforms. He is a Summa Cum Laude graduate of University of California, Irvine with a Master of Science in Biomedical Engineering and a minor in management. His master's thesis involved development of signal processing algorithms for extra-cortical recordings based on which an academic paper has been published.With a keen interest in emerging SaMD/SiMD technologies and in particular AI, his latest activities in this area include a speakership on AI/ML applications at MD&M West 2024 and a podcast on applications of machine learning in medical devices. He is currently a member of the AFDO/RAPS Healthcare Collaborative working group on Good Machine Learning Practices (GMLP). In 2024, the working group is working on preparing a mock FDA submission for an AI-enabled device as a reference for the industry.
Current workplace
Ashkon R.'s current company
Company context helps verify the profile and gives searchers a useful next step.
11 roles
Ashkon R. work experience
A career timeline built from the work history available for this profile.
Director, Quality Management Systems
Recognized by Fast Company as 2022 Most Innovative Companies leading a new category of clinical-grade, safe and effective drug-free mental health programs available through CVS Health (Caremark), Evernorth (Express Scripts/Cigna), NHS Scotland. Owned the QMS designed to sell multiple digital therapeutics in the US/UK/EU markets- Led growth of the QMS team.
Feb 2022 - Nov 2023
Senior Manager, Technical Product Management
- Externally-facing role in the professional services organization. Delivering regulated SaMD (Software-as-a-Medical-Device) products for leading pharmaceutical clients- Responsible for product definition and ensuring delivery to scope and timelines- Own client interaction, grooming, release planning, sprint management, scrum ceremonies- Led large.
May 2020 - Feb 2022
Technical Program Manager, Software Quality Engineer
- Develop the software quality management system in compliance with ISO 14971, ISO 13485, ISO 62366, IEC 62304 and 21 CFR Part 820 and 21 CFR Part 11- Project support to ensure compliance to the quality system around risk management, design controls, software development lifecycle (SDLC) and post-market surveillance (PMS). Author risk management.
May 2018 - May 2020
Principal Software Qa Engineer
- Led Development of the Software Quality System to the point of compliance with IEC 62304:2006+A1:2015, and the various FDA Guidances- Authored and reviewed the software quality deliverables for development of a multi-piece platform of embedded, mobile (Android), and web software applications (C++, Javascript)- Assisted with the system engineering.
Apr 2016 - May 2018
Senior Software Quality Engineer
- Led SW Quality for a multi-piece embedded system of class B and class C software (C++, C#)Responsible for NPD (New Product Development) SWQA activities from concept through Design Transfer- Responsible for risk management activities including Software Hazard Analysis and Cybersecurity - Designed and oversaw the implementation of the software defect.
Apr 2015 - Apr 2016
Software Quality Engineer Ii
- Led SW Quality for a sustaining project that resulted in 33% cost savings per unit- Re-designed the test suite architecture on a legacy product to improve efficiency by 25%- Prepared and released quality documents such as RTM, Testing Summary and Known Issues Reports
Apr 2014 - Apr 2015
Software Quality Engineer I
Apr 2013 - Apr 2014
Intern, R&D / Clinical
Breathe technologies designs and manufactures non-invasive open ventilation (NIOV) devices for patients with chronic obstructive pulmonary disorder (COPD), as well as continuous positive airway pressure (CPAP) devices for treatment of sleep-related breathing disorders. Responsibilities:Design and Development of Detection Algorithms (MATLAB)Development of a.
Mar 2012 - Feb 2013
Intern, Regulatory Affairs
ev3 neurovascular designs and manufactures various products including Micro Catheters, Guidewires, Retrieval Devices, Stents, Coils, and Liquid Embolics. Responsibilities:Correspondence with the FDA, Notified Bodies and other International ConsultantsRoutine Regulatory Submissions (PMA Annual Report, International Document Updates)Maintenance of the.
Jun 2011 - Sep 2011
Intern, R&D
Prelude Corporation develops in-vitro diagnostic assays to predict the outcome of Ductal Carcinoma In Situ (DCIS).Responsibilities:Diagnostic biomarker assay test developmentPreparation for Validation in a CLIA labLocating micro-toned tissue libraries around the world with traceable outcome dataContacting the responsible parties for potential.
Jun 2010 - Sep 2010
FAQ
Frequently asked questions about Ashkon R.
Quick answers generated from the profile data available on this page.
What company does Ashkon R. work for?
Ashkon R. works for EnGenius Solutions LLC.
What is Ashkon R.'s role at EnGenius Solutions LLC?
Ashkon R. is listed as Non-BS QMS Advocate. SaMD/SiMD/AI/ML. Medical Device QMS Strategist. at EnGenius Solutions LLC.
Where is Ashkon R. based?
Ashkon R. is based in Costa Mesa, California, United States while working with EnGenius Solutions LLC.
What companies has Ashkon R. worked for?
Ashkon R. has worked for Engenius Solutions Llc, Big Health, Brightinsight, Verily Life Sciences, and Vital Connect, Inc..
How can I contact Ashkon R.?
You can use AeroLeads to view verified contact signals for Ashkon R. at EnGenius Solutions LLC, including work email, phone, and LinkedIn data when available.
Find 750M verified contacts
Search by job title, company, industry, location, and seniority. Export verified B2B contact data when you need it.
Start free trial