Stefan Robert Email & Phone Number

San Diego, California, Us

Empowering our team of talented HW engineers and technicians to thoroughly verify our products and provide accurate evidence of safety and performance.

San Diego, California, Us

Accountable for all V&V activities in new product development projects. Responsible in defining this new role in Dexcom.

San Diego, California, Us

Accountable for all System Engineering activities in development of new products. Lead Systems Engineer responsible for HW subsystems on next generation CGM products for consumers and Hospital markets.• Enabled smooth EU filing by ensuring proper assignment of all V&V activities, resolving gaps with managers, and ensuring deliverables were completed per expectations at filing. • Led the Alert System architecture definition involving UX, HF, R&D & DVT teams, resulting in ~260 test cases and serves as the foundation for Alert System development for all Dexcom products.• Led the Wearable leakage current specification to closure within 2 months of my involvement by working closely with HW, Algo, Sensor team to develop leakage model and error budget. • Enabled the FW team to virtually eliminate false wake up issues (3% to << 0.01%) by leading the creation of statistical models, user studies and FTA analysis serving as input to the FW algorithm. • Enabled the Real-Time API team to demonstrate their interoperability strategy to regulatory agencies by collaborating with RA & QA to create the Interoperability Communication Plan.• Enabled the Hospital Market team to define the Minimum Valuable Product for COVID-19 projects by using Pugh matrices to decide on the best option and present to internal stakeholders.

San Diego, California, Us

Corporate expert in standards accountable for the product strategy for safety, EMC, radio compliance. Represents Dexcom on International Standards committees. QE Design Assurance Lead on new projects.• Enabled yearly saving of $3.8MM for the Falcon Receiver Charger by convincing RA, QA & R&D of the proper safety strategy to eliminate unnecessary specifications and maintain adequate safety level.• Avoided forced obsolescence of the G4 product in EU markets using my expert knowledge of the EU Blue Book state-of-the-art expectation to justify deviations from harmonized standards requirements.• Reduced by 75% effort to review standards changes and eliminated backlog of 400+ standards to review by creating process & automated tools. Reduced reviews from ~5/month to ~1 per 2-months.• Led the selection of a standards provider which cut cost by 2/3 (~$60K/yr to ~20K/yr) and negotiated access to red-line services which saved 100s of hours when reviewing updates to standards.• Reduced time from weeks to a few hours to evaluate effort and cost of radio compliance activities by leading the creation of a reference tool that summarizes the efforts and costs needed for all countries.• Brought G7 risk management into compliance with IEC 60601-1 by defining method to define Essential Performance using the ISO 14971 standard and without creating extra documentation.• Led creation and execution of the remediation plan for products compliance with current radio regulations. Updated products compliance and SOP preventing gaps in new product development.• Led the implementation of Dexcom corporate compliance program to the product electronic and packaging waste regulations by presenting business case to executive leadership, confirming gaps, set-up contractual agreements with in-country agencies, leading creation of compliance evidence, updating SOPs and hiring new manager role now responsible for this process.

London, Gb

Accountable for all design verification activities (SW, HW, MEC, Safety) and Engineering / Manufacturing Test Automation for a team of 2 managers and 15 engineers. Responsible to re-structure the teams to enable faster throughput and re-use of engineering test resources.• Instrumental in the on-time development of the SENTIVA neurostimulator platform in 18 months from planning to submission by implementing metrics which enabled team leadership to predict deviations to work completion in advance and enabled preventive actions to meet timeline commitments.• Led the on-time delivery of design verification activities for the SENTIVA neurostimulator platform by implementing data driven metrics to predict work velocity and enable timely resource correction. • Significantly reduced costs of engineering, verification, and manufacturing tests by promoting a leader with strategic mindset to implement the vision of scalable and re-usable test systems.

London, Gb

Design Assurance Quality Engineering team was moved to the R&D organization. Same accountability and adding support to the R&D organization during development• Led the implementation of DFSS techniques with the design team to eliminate un-necessary reverse engineering activities during characterization, verification, and design transfer activities.

London, Gb

Accountable for all electrical and mechanical design verification activities for a team of 3 engineers and 1 technician. Corporate Subject Matter Expert on product safety, EMC and other medical standards. Responsible for technical leadership of all deliverables defined by the product development process to ensure engineering best practices and design history files compliance with regulations and standards.• Led implementation of master V&V plans, set the expectations of all verification teams, coached individuals, and monitoring quality of work to significantly reduce regulatory submission review time.• Enabled cost reduction of the programmer tablet of more than $2MM per year by convincing Executive Leadership of the correct certification strategy required for our customers. • Defined the strategy to remediate a major design control audit finding with legacy products, led the 1 ½ year effort with weekly progress to FDA, represented & defended our position directly to auditors. Results: no warning letters and praise from FDA as a model to address findings in a timely manner.• Eliminated unnecessary burden for all verification teams by simplifying process which improve team’s quality of testing and reporting and reduced SOP by half (~20 pages to less than 10 pages)• Enabled verification teams to strongly defend Safety/EMC strategy with regulatory agencies by training teams on state-of-the-art Safety/EMC planning techniques and testing expectations.• Neuromodulation division representative on international standards committees for IEC 60601-1, ISO 14708-3 by authoring subclauses and proposing modifications that are now part of the standards. • Developed relationships with FDA’s EMC experts to experiment on the impact of TSA scanner on neurostimulators leading to a white paper on their usage with implantable devices.

London, Gb

• Led investigation of an ASIC unrecoverable field failure within 6 months after hiring by using fault-tree, modeling, and engaging design team to perform required analysis to confirm root cause.• Defined ASIC critical parameter to screen, test method to implement and worked with supplier to ensure adequate budget was available to cover costs for implementation of in-line screening method.• Eliminated all out of box failures of compact flash cards by root cause & fault-tree analysis and demonstrating to supplier gaps in their 100% functional test and led implementation of corrections.• Enabled the SW QA team to meet aggressive timeline by ramping up to a project in < 4 weeks and providing key feedback on verification discrepancies and support to fix issues with design team. • Improved the testability of requirements and specifications by providing training and reference material to the R&D HW and SW organization on good requirements creation practices.

Malmö, Skane, Se

Hired to resolve major electrical engineering issues in a high growth, fast paced environment and accountable for all electrical and software design, verification, validation, manufacturing of all products at the Magog division (~30 product lines). Accountable for operation of internal test labs used daily by ~25 engineers/technicians. Manage team of 6-8 direct reports. Responsible for high profile investigation and compliance activities. Corporate Subject Matter Expert on product safety and EMC standards.• Reduced test lab setup time from 2 days to < 1 hour on 30+ automated test stations by defining the vision, hiring a hands-on lab manager, and developing first lab KPI for new resource requests. • Led the investigation a major EMI susceptibility issue and implementation of HW, SW and Mechanical mitigations to eliminate problem within 6 months of hiring. • Significantly improved turnaround time for IEC 60601-1 certifications from 2-3 months to < 4 weeks by implementing on-site compliance testing with test lab partners. • Enabled major costs savings of PCBA by determining commonality between ceiling and floor platform while creating the first Use Case and User Needs document based on UML concepts of the division.• Led the design of the new floor and ceiling hoists platform with internal and remote teams located in Canada, U.S.A., and Israel.• Enabled the division to resume shipping of flagship product line < 1 month after losing right to bear the NRTL Safety Mark due to previous administration misunderstanding of obligations by defining and leading the remediation strategy and directly defending our resolutions to the NRTL National Adviser.• Significantly reduced the cost of PCBA outsourcing to low-cost countries by evaluating alternates, standardizing PCBA specifications and reducing the number of components used in our assemblies.

Sherbrooke, Québec, Ca

• Teach basic principles of project management in a context of product development process. • Teach basic skills in project and product risk management. • Give technical support to student in circuit board design and FPGA development tool.

Ca

• Design In-Circuit test fixtures with embedded electronics to reduce the programming time of device on the production line by half. • Design an automated test system controlled in BASIC using GPIB communication. • Design a test fixture with an embedded cooling system controlled in assembly language. • Perform Design for Test (DFT) analysis on circuit boards to improve test coverage prior to the introduction on the production floor.

Santa Clara, Ca, Us

Support In-Circuit Test Engineers in the qualification of In-Circuit test fixture and software

Santa Clara, Ca, Us

• Assist test engineers in the development and maintenance of In-Circuit test fixtures.• Create a custom test fixture for BSDL file generation.

Master In Applied Sciences - Engineering (Msca), Microelectronics - Analog Design, Low Noise Preamplifiers Asics

Bachelor Of Science In Electrical Engineering (Bsee), Electronics

Associate'S Degree, Avionics Technician