Quality Manager

• Jul 2023 - Present

Quality Systems Manager - Surgical Robotics

• Apr 2022 - Jul 2023

- Provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines;- Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance;- Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations;- Lead audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits;- Prepare reports and/or necessary documentation (ex Corrective and Preventative Actions) and provide to applicable stakeholders, both internal and external;- Co-ordinate legal requests in support of government investigations or litigations;- Ensure the quality assurance programs and policies are maintained and modified regularly;- Facilitate uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of company's mission globally. Show less

Principal Software Verification Engineer - Surgical Robotics

• Jan 2021 - Apr 2022

• Provide technical and verification leadership for the software test engineering team in the Surgical Robotics Division• Lead definition and implementation of different software testing techniques to increase test coverage and optimize automation vs. manual testing• Employ different process improvement methodologies, including SAFe Agile and Design for Reliability and Maintenance (DRM), to enable breaking barriers across the organization and to optimize ways of working• Develop and deliver SW Verification deliverables to support regulatory submission and release of product to the field• Understand the technical behavior of the system, architecture, software requirements with an aptitude to identify product defects in all phases of development• Coordinate dry runs and formal Verification activities as required• Collaborate with technical engineering teams, and mentor junior test engineers Show less

Principal Software Design Assurance Engineer

• May 2020 - Jan 2021

- Support the activities related to the design, development, and ongoing maintenance of medical device products and supporting software - Provide quality oversight and guidance for software design and development, for product and non-product software - Review deliverables of the development lifecycle for correctness and compliance to policies - Lead major efforts, or phases of projects, to resolve Software Quality-related problems - Lead/support Risk Management activities to ensure software design and process shortcomings are identified and appropriately addressed - Support the product development teams in the adoption and use of best practices, Quality tools, and Software Design Control methodologies - Investigate/reproduce customer problems/issues - Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP’s, QSR, ISO 9001, EU MDD, EU MDR Show less

Engineering Lead, Lotus NICU, Connected Care Informatics

• Aug 2019 - Apr 2020

Engineering and Verification Lead for Lotus NICU, a systematic solution spanning software, video, RFID, hardware and real-time analytics to dramatically improve NICU clinical outcomes and parent engagement. Lead multiple teams in Cambridge, Denver and India to product high quality software, while following documented processes for FDA/QMS regulatory compliance. Estimate and control engineering timelines and costs, provide visibility to upper management of progress, and resolve roadblocks and conflicts. Write verification and validation plans and protocols, review and approve test cases, and generate trace matrix to show evidence of test coverage. Mitigate project and application safety risks through dFMEA/uFMEA. Provide proactive input to project plan, requirement review, development plan, usability test plan, validation plan, and other QMS deliverables. Hands-on contributor to project success, assisting in design, testing, and site support. Architected and implemented Gherkin-based automation test framework allowing all testers to contribute to CICD regression tests of application functionality and automated reporting. Show less

System Verification Lead, Lotus NICU, Clinical Informatics Advanced Development

• Feb 2018 - Aug 2019

System verification lead for Lotus, an advanced development project seeking to be a gamechanger for care of prematurely born infants in the NICU. Set testing strategy, and perform verification on components of the Lotus system. Review documents and requirements (SRA, PSRA, CRS, SRS, etc.) and ensure traceability for verification efforts against them.

Software Test Manager, Hospital to Home Outpatient Products

• Apr 2014 - Feb 2018

Oversaw test efforts across multiple scrum teams located in Baltimore, MD; Bangalore, India; and Eindhoven, the Netherlands, working on a telemedicine medical device incorporating a cloud-based clinical portal and Android-based patient-facing software. Created new test processes for FDA traceability, represent test spheres in TÜV SÜD and FDA audits, and ensured American federal and global regulatory compliance to 21 CFR 820 and ISO 13485. I managed defect review meetings and participated in the evaluation of potential patient safety issues per ISO 14971 regulations. Reviewed and approved test cases, managed and reported on status of testing for projects, and addressed or escalated issues related to testing. My major accomplishments included:► collaboration in a Six-Sigma Greenbelt project which reduced defects and customer complaints by over 70% ► led transition from manual to automated testing, resulting in an increase from 0% to 50% automation and counting in just over a year Show less

HIPAA X12 835 ERA/EFT Test Lead

• Jul 2013 - Mar 2014

I led a four-person team for testing the upgrade of Dean’s electronic remittance to meet HIPAA and Healthcare Reform standards. I also coordinated testing of the introduction of Dean’s health plans on Healthcare.gov., and helped facilitate Dean's transition from Waterfall to Agile. I led a four-person team for testing the upgrade of Dean’s electronic remittance to meet HIPAA and Healthcare Reform standards. I also coordinated testing of the introduction of Dean’s health plans on Healthcare.gov., and helped facilitate Dean's transition from Waterfall to Agile.

Quality Assurance Lead

• Sep 2001 - Jul 2013

I corresponded with development leads to determine feature list, manage development and testing timelines, and ensure final quality of release. I collaborated in the creation of company-wide testing practices for validating the Epic release package and the testing of post-release patches and in the setup of the review and customer notification process for safety-related defects. I spearheaded the testing of internationalization and translation readiness for Epic's software in readiness for sale to the European market. My major accomplishment was establishing several test teams from scratch on products having no previous formal testing. Show less

Quality Assurance Lead, Electronic Claims and Remittance

• Jul 1998 - Sep 2001

I was the sole tester for Epic’s transition to ANSI X12 837 (claims) and 835 (remittance) for HIPAA compliance. I also achieved certification of compliance against multiple private and state payors and clearinghouses. Served as claims implementation coordinator for 4 Resolute installs and provided technical support to customers. Built up the test team to 5 testers, in an area which previously had no formal QA.

Quality Assurance Engineer, Resolute Professional Billing

• Jul 1996 - Jul 1998

I served in the Resolute Professional Billing division. I wrote and executed test plans for various modules. My focus was on the billing, claims, reporting, and daily and monthly balancing portion of the modules.