Daniel Keenan
Verified Expert in Product Management
Product Manager
Beachwood, NJ, United States
Toptal member since June 16, 2021
Daniel is an accomplished R&D leader and engineer with an in-depth technology background and 20 years of experience. Throughout his tenure at Angel Medical Systems, he has taken on increasing levels of accountability and authority to drive the R&D process. As a leader in the medical design space, Daniel creates connections and provides key stakeholders with information about existing and emerging technologies and resources that advance product development and launch efforts.
Project Highlights
Expertise
- Agile Product Management
- Design Validation
- ISO 13485
- Medical Devices
- Medical Product Manager
- Medical Software
- Product Owner
- QA Test Plan Management
Work Experience
Senior Product Director, Medical Device
NuvoAir
- Served as the technical product owner for the company’s Class I/Class II medical devices and related mobile applications. Acted as the lead product director for new SaMD AI applications for mobile/home medical applications and distributed clinical trials.
- Led company regulatory (technical files, 510(k)) responses to regulatory authorities for regulatory filings, audits, and recertifications.
- Acted as agile product owner for a SaaS clinical trial platform and related hardware and 3rd-party integrations, including web and mobile platforms.
- Authored the design control regulatory strategy for software as a medical device.
- Led and managed new generation handheld mobile medical device, including hardware, embedded firmware, and mobile applications.
Vice President, R&D
Avertix
- Headed the company's technical division, reporting directly to executive management and overseeing all R&D, including product development, continuing engineering, partnerships, and employee technical services.
- Managed a manufacturing restart from no capacity to a salable product delivered to market in 13 months. The 1st revenue was generated within 16 months of the restart.
- Directed the operations and manufacturing for the Asia-Pacific launch of the product line.
- Performed the functions of a chief information officer, including design, implementation, and support for internal computer systems, remote access, and 3rd-party access.
- Managed the company’s supply chain and manufacturing operations from PCB build to final test, inspection, and order fulfillment.
Director of Clinical and Data
Avertix
- Led clinical field engineers who were responsible for three clinical studies, including a pre-market approval study for an implantable medical device, involving 1,000+ subjects and 100 centers in the United States, Europe, and South America.
- Determined and composed requirements for lower-level technical support personnel supporting company products. This included test equipment, data storage, and transport requirements.
- Managed data monitoring functions, including clinical data source verification for all clinical trials (US and EU), with 250+ data points and local EMRs to support the FDA PMA application.
- Oversaw duties outsourced to the clinical research organization, including Oracle database administration and updates, user adds and changes, and database schema changes and testing.
- Served as the head of IT, responsible for design, implementation, and support for internal computer systems, remote access, and 3rd-party access.
Tier 4 Technical Support
Angel Medical Systems
- Provided top-level technical support for company products worldwide and served as the R&D point of contact for all field support personnel, including clinical-related issues initiated by field clinical engineers.
- Coordinated the R&D response to escalated field problems, R&D planning of software upgrades, and training updates, and served as a general liaison role between R&D and the field organizations.
- Led efforts to reproduce and debug complex field problems and to test potential fixes for known field problems, using hardware test tools and software debugging applications.
Member of the Technical Staff
Avaya
- Provided software QA in a complex environment using Avaya’s VoIP portfolio of products, including Avaya Communication Manager, IP phones, wireless infrastructure, and data products.
- Served as a technical expert to support resources in the local and extended organization, which included training and educating various audiences in difficult technical concepts.
- Supported internal and external sales teams in positioning VoIP products for several high-profile customers.
- Owned system configuration and served as the main point of contact for an external trial program.
- Created formal data networks internally within labs and externally at customer sites.
Project History
Engineer Training Program
Served as the lead designer and instructor for an engineer training program on new products and clinical processes.
Skills
Tools
Skype, Zoom
Paradigms
Software Testing, Manual Testing, Agile Product Management, Azure DevOps, Agile
Platforms
Windows Server 2016, MacOS
Other
Software QA, Medical Devices, Medical Software, Technical Support, Healthcare Product Manager, Team Leadership, Team Management, Medical Product Manager, Clinical Research, Good Clinical Practice (GCP), Clinical Trial Management System (CTMS), Product Owner, Manufacturing Product Manager, IEC 60601, Design Validation, Windows 10, QA Test Plan Management, Windows, Firmware Validation, Validation, Healthcare Software, Project Management, Embedded Systems, Hardware, Technical Product Management, Firmware, Early-stage Startups, Life Science, SaaS, Hardware Design, iOS, Agile Practices, Supply Chain Management (SCM), Manufacturing, Amazon Web Services (AWS), ISO 13485, ISO 14971, IEC 62304, Apple, Cisco Firepower, Product Vision, Avaya Software, Capability Maturity Model Integration (CMMI), Microsoft Teams, Avaya Enterprise, Training & Training Content Development, R&D, Embedded Hardware, Artificial Intelligence (AI), APIs, Mobile UI, Android, Agile Sprints, Agile Delivery
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