David Shanes Email & Phone Number

Santa Cruz, Ca, Us

Fullpower®-AI delivers a complete IoT PaaS platform vetted and deployed worldwide, for machine learning, remote contactless biosensing, and end-to-end smart connected devices in life sciences, health, and biotechnology. In addition, Fullpower's platform is backed by 135+ patents and is ISO/IEC 27001 and SOC 2 Type II certified.Responsible for managing the Regulatory and Compliance efforts for Fullpower®-AI and advancing its solutions into the healthcare and medical device spaces. - Management Representative for the company.- Data Protection Officer for the company.- Implemented an electronic Quality Management System.- Reviewed and updated all QMS documents to be more fully compliant with QSR and ISO 13485.- Reviewed and assisted in updating all product DHF documentation to be ready for US FDA 510(k) filing for Class II medical device.- Worked with 3rd party vendors to ensure that their product documentation was complete and compliant with requirements.- Drove compliance/security/privacy efforts to achieve ISO/IEC 27001 certification, SOC 2 Type II attestation, and GDPR compliance.

Device Design Solutions was created to help companies get their medical device systems completed on time and on budget so they can be approved by the appropriate regulatory agencies and released to the market.Getting your products to market and in the hands of your customers and patients is vital to allowing us to realize our mission of helping to improve human health.Specializing in Medical Device R&D: Software and Hardware Engineering, Quality Assurance, Product - Project Development/Management, Manufacturing, and overall Leadership/Management.• Consult with medical device companies to assist with all product development activities.• Work with all employees, including Executive Management – C-Suite.• Review and recommend changes to: o Product and project management processes and activities. o Software and hardware engineering processes and activities. o Manufacturing processes and activities. o Quality assurance processes and activities. o Regulatory compliance processes and activities. o Vendor qualification, review, and engagement. o Communication and decision-making processes. o Meeting management, meeting structure processes and activities. o Company culture and employee engagement. o Due Diligence. o Mergers and Acquisitions. o Intellectual Property posture and strategy.

San Diego, Ca, Us

Responsible for maximizing TruMed Systems, Inc. engineering and manufacturing performance, hardware and software development and information security to help in achieving our business goals. Provide leadership and strategic direction to the company’s overall engineering program, including all products and systems, business applications and tools for internal and external use and for expanding and leveraging product and systems to develop new and next generation opportunities.* Chief Security Officer for the company.* Responsible for all internal and external Engineering activities – System, Electrical, Mechanical, Software and Quality Assurance.* Responsible for all Manufacturing activities for multiple product lines, including new product manufacturing, sustaining engineering, rework/RMA, logistics.* Responsible for all vendor/partner management activities.* Responsible for intellectual property portfolio management.* Work with all cross-functional teams to mature processes and procedures to support company strategic growth initiatives.* Responsible for looking for, qualifying, and engaging with a second contract manufacturer outside the United States.

Pacheco, Ca, Us

Managed multiple groups within the Quality and Regulatory department of up to 18 employees, contractors and interns including Quality Assurance, Quality Control, Quality Systems, Regulatory Affairs, and System Verification.* Management Representative for the company.* Responsible for taking the company through multiple second and third party audits.* Lead the company through an overhaul/remediation of the Quality Management System to bring it in compliance with ISO 13485:2016. Resulted in a successful audit and ISO 13485:2016 certification.* Lead the company through a subsequent update to the Quality Management System to bring it in compliance with Medical Device Single Audit Program (MDSAP) requirements. Resulted in a successful audit and MDSAP certification. * Overhauled the QMS Management Review and Internal Audit processes. * Started a new Post Market Surveillance program. * Instilled a new culture of Risk Analysis, including identification, analysis, and mitigation. * Work cross-functionally to decentralize quality ownership and accountability to all departments and to instill a quality-oriented mindset (Culture of Quality) in all day-to-day activities across the company.* Work with senior management and C-suite to turn the company culture, including inter- and intra- team collaboration, meeting effectiveness, and decision-making.* Certified ISO 13485:2016 Internal Auditor.* Certified in Root Cause Analysis for Life Science Investigations.* Attended Medical Device Single Audit Program (MDSAP) course.

Malvern, Pa, Us

Managed multiple groups within the R&D department of up to 45 full-time software, hardware, biomedical engineers, project managers, QA, contractors and interns domestically and internationally – 6 direct reports.• Received highest engagement score in the company wide engagement survey.• Defined and implemented corporate technical roadmap.• Completed budgetary responsibility for multi-million-dollar R&D budget.• Conducted due diligence for merger/acquisition partnerships and competitive analysis.• Worked with government regulatory agency (FDA) and standards bodies.• Drove all R&D aspects of Intellectual Property (IP) to ensure Freedom to Operate, working with lawyers, designers/architects/scientists, as required, to write/submit patentable inventions.• Worked with global external vendors/partners to develop statements of work/contracts/development agreements.

Malvern, Pa, Us

Managed the department of up to 15 full-time engineers, contractors and interns.• Technology and architecture driver; the right tools and processes for best of class products.• Drove product definition, architecture, development and ran project management for multiple concurrent projects.• Worked significantly on building/repairing relationships between groups in San Diego and other local/remote groups.• Managed tool selection process – requirements definition, vendor identification, pricing, purchasing.• Drove late projects by performing requirement/implementation gap analysis and creating momentum and fostering ownership and accountability.• Orchestrated all embedded and supporting PC application product software that includes mobile, cellular, Bluetooth, low power wireless (1GHz) technologies in C, C++, C#, and Java.

Lake Forest, Il, Us

Managed department of up to 80 full-time managers and engineers, contractors and interns including local, remote domestic and off-shore staff divided into five development teams.• Oversaw all software development for entire company.• Complete budgetary responsibility for multi-million dollar software development budget.• Drove all project management and requirements definition activities including new development and support activities.• Directed the definition and development of “game changing” products to customers.• Introduced first Scrum/Agile development projects training developers on processes and running spin kick-off/close-out meetings and was the process champion gaining cross functional support.• Worked with the customers on HIPAA, Healthcare IT, HL7 related issues.• Drove system and software development and integration to streamline overall system performance and improve department’s reputation within company.• Collaborated with government regulatory agency (FDA) and standards bodies.• Worked on Intellectual Property (IP) team to ensure Freedom to Operate, working with designers/architects as required, for Hospira and to review patentable inventions.

Lake Forest, Il, Us

Managed and led Engineers for Drug Library Editor and Medication Management Unit development teams acting as a manager, team leader, team builder, and advocate throughout all levels of management.• Led all project management and requirements for projects delivered the most on time within the entire software department directly contributing to on time product delivery to customers.• Drove system and software development and integration to streamline overall system performance.• Managed other senior and junior software engineers, including interviewing, hiring, reviewing, mentoring, career guidance, tasking, design and code reviews.• Led the design and development of “best of breed” features that greatly outpaced the competition.• Developed and maintained project plans for multiple versions of products including task definition, prioritization, assignment, updating and status reporting.• Provided technical support for fielded applications as required (first and second level).• Provided 24/7 support for applications supporting hospital operations, managed escalation and resolution.• Worked to foster an environment of open communication and positive attitude.

Us

• Consistently delivered on time, quality versions of software deliverables maximizing utilization of resources directly resulting in company getting additional project funding from the customer.• Drove significant systems integration activities across Department of Defense projects.• Managed other senior and junior software engineers, including interviewing, hiring, reviewing, mentoring, career guidance, tasking, design and code reviews.• Created Statements Of Work (SOWs) to be used as the basis for contracting activities, including budgeting and deliverables scheduling.• Managed the Work Breakdown Structure (WBS) for definition and refinement of assignments, tasks and project timelines and deliverables for multi-million dollar funding effort directing team of 15 engineers.• Designed, developed, tested and documented application for the XTCF (eXtensible Tactical C4I Framework) project funded by Office of Naval Research (ONR) in Java/J2EE. This was a revolutionary platform for integration of disparate systems that had not been done before.This system had significant QOS requirements for throughput, response time and availability.• Designed, developed and integrated products covering complex system multi-level security.

San Diego, Ca, Us

Washington, Dc, Us

* Titles included: Communications Officer, COMSEC Materials System (CMS) Custodian, Electrical and Auxiliaries Officer, Chief Engineering Officer, Missiles Officer, Naval Tactical Data System – Combat Information Center Officer* Extensive experience leading, managing, training, counseling and evaluating 20 – 110 personnel* Consistently increased personnel job qualifications by up to 500%* Extensive experience scheduling tasks, projects, training and maintenance* Administered quarterly budgets of $15,000 - $150,000* Ordered and controlled over $115 million in weapons, including missiles, firearms and ammunition* Thorough knowledge of Naval warfare, communications and intelligence systems* Experienced in the use and management of cryptographic material and equipment* Extensive professional military education, consistently ranked first in all classes

Bachelor Of Science - Bs, Computer Science

Master Of Science - Ms, Computer Science