Jo-Ann L. Email & Phone Number

Billerica, Massachusetts, Us

• Product and program management supporting next generation RUO and IVD platforms including hardware/automation, software, and consumables• Drive product vision, strategy, and timeline to achieve product success and significant market share • Manage program communications with C-suite • Define marketing, user, and product requirements • Manage communications with design and development firms, contract manufacturers, and major customers • Manage communications with key stakeholders across all departments within the organization • Manage existing RUO instrument portfolio, supporting sustaining product improvements and customer requests• Member of QTRX Innovation Committee

Lowell, Massachusetts, Us

Executive Leadership• Full responsibility for Product, Engineering, Manufacturing, Quality, and Regulatory strategies for the business• SME for medical device product development, medical device regulations, and digital health technology• Led weekly executive management meetings promoting cross functional collaboration and communication• Communicated product strategy, including timeline and budget updates, to board of directors• Supported CEO with fundraising planning for Series B and additional intermediate grantsProduct/Engineering• Created, drove, and reported on go-to-market strategy for flagship product, along with CEO and Clinical Research• Owned Minimally Viable Product (MVP) definition, timeline, and budget• Responsible for product pipeline and future roadmap• Supported existing prototype device, under Investigation Device Exemption (IDE), owned hardware (pneumatic, electrical, and apparel), firmware, and software)• Managed customer operations, including complaint management and client support• Managed and mentored product development team• Managed communications with external design firm, contract manufacturer, suppliers, and contractorsQuality/Regulatory• Led all high-level quality and regulatory strategy decisions surrounding FDA and CMS regulations• Advised on digital health industry trends, including new/updated regulations• Owned IDE strategy for current prototype device and supported Clinical Lead with IRB submission• Developed and maintained SOPs, responsible for QMS compliance and effectivity (21 CFR 820 and ISO 13485)• Led integration and rollout of electronic QMS software (Greenlight Guru)

Boston, Massachusetts, Us

• Led continuous improvement and sustaining engineering activities for several product lines (Class I and II) in medical device biosensors portfolio• Managed new feature launches and product introduction to new markets• Owned technical files, DHFs, DMRs for medical device biosensors portfolio

Boston, Massachusetts, Us

Project Lead: • Led successful, on-time completion of design and development project for Class I device - MDR and FDA 510k (8 months, 30+ resources in US, Sweden, UK, Ireland, China, and Israel) • Responsible for the technical file and device registration as Project Lead • Managed project communication to senior leadership, including the CEO• Managed communications with external design firm, contract manufacturer, suppliers, and contractors• Led EU/UK market launch focusing on user experience, regulatory strategy, and business needsProduct Development Leadership: • Led company initiative for streamlined Product Development Process while ensuring compliance to regulations• Collaborated with senior leadership for pipeline and portfolio management • Collaborated on hiring strategy for product development team with HR and Director of Product Innovation • Supported launch of new PLM system in Arena as Mechanical, Manufacturing, and Product SME• Created PMO group to coordinate with other project and product managers• Mentored co-ops, entry-level engineers, and engineers with limited knowledge in medical device product development• Product development representative on CAPA review board, led several CAPAs to resolution • Recognized with company end-of-year award for "Focus on what matters" Manufacturing/Supply Chain: • Coordinated supply chain, including communication with contract manufacturer and downstream suppliers• Responsible for supply chain management and strategic sourcing • Responsible for operations planning with senior leadership

Newton, Ma, Us

• Technical lead for cancer detection imaging device (Class III) for real-time identification during tumor excision surgery (handheld probe, cart, misc. OTS electronics) • Led transfer to manufacturing (CMO, contract manufacturer), as well as managed 2nd and 3rd tier supplier/vendor relations• Successfully led first pilot build of commercial product at CMO on an aggressive timeline and limited resources • Managed vendor selection based on technical needs, regulatory compliance, and business needs • Generated and maintained project plan based on business risks and project risks while maintaining quality and safety • Resource management and task delegation for contractors and technicians • Supported FDA PMA submission for Class III device• Founding member of the Lumicell Professional Women's Group

Bedford, Ma, Us

Wash Design 2.0 (July 2018 to Sep 2020):• Completed design for two alternative wash designs (due to requirements change) on time and on budget• Designed new system to decrease wash and dry time by approximately 10% - significantly improves overall system throughput• Planned new design effort in MS project, spanning 6 months and 10 resources from various departments • Led significant cost reduction effort on next generation system (decreased cost of parts from alternative vendor, removed need for PM activity 2X a year through improved reliability and product life) Wash Design 1.0 (Feb 2018 to June 2018):• Used PTC Creo 4.0 to design electromechanical wash system for next-generation hematology diagnostic system (Class II)• Designed modules that meet requirements, cost targets, and passed mechanical testing, i.e. life testing (30,000 cycles)• Designed system that resulted in 90% cost reduction - maintaining functionality and precision• Collaborated with various groups for integration activities and proof-of-concept testing• Led module concept reviews for project feasibility phase • Completed and managed fluidic diagrams, build instructions, and configuration management files• Completed and managed sequence diagrams for wash processes to be used as communication tool with software engineeringMisc Activities:• Lab manager for mechanical engineering project area - ran 5s workshop to improve safety and efficiency• Identified gap in design team skill set and organized an in-house Python training class• Trained team on Design Thinking Process and Brainstorming Principles

Bedford, Ma, Us

Fort Worth, Tx, Us

Design Work: • Worked at KMC Systems (medical device R&D consulting division of Elbit Systems)• Patent Pub. No. US 2019/0287780 A1 - "Methods for Aligning a Light Source of an Instrument, and Related Instruments"• Designed medical diagnostic equipment (Class II), in the fields of general chemistry and microbiology, focusing on user needs, manufacturability, and reliability• Used SolidWorks Simulation and SolidWorks Flow Simulation to drive design decisions • Designed modules for a complex electromechanical system that utilizes vacuum and laser technology • Led design reviews and compose related documentation for the Design History File• Wrote test procedures for pre-verification and validation • Managed bill of materials for team and ensure arrival of parts for developmental builds • Supported sustaining engineering work on existing products related to specification changes• Worked closely with customer group to understand and define design and functional requirements• Supported manufacturing team with system builds and design transfer Misc Activities: • Hosted multiple design thinking workshops and led brainstorming sessions for multidisciplinary teams • Supported integration of the new PLM system for the Engineering department • Part of Simulation Review Team to aid and review FEA simulation set up and results across various projects

Fort Worth, Tx, Us

Marlborough, Ma, Us

• Assisted the sustaining engineering team in supporting existing enteral feeding tube products• Managed design verification testing due to a major design change resulting from new ISO standards• Designed, documented, and performed conditioning tests for various enteral feeding port products• Volunteered at a company-wide STEM outreach program for middle school students • Competed in the 4th Annual Boston Scientific Innovation Challenge in the pulmonary field• Composed and presented a final co-op PowerPoint to colleagues and managers in the Endoscopy R&D department

Chicago, Il, Us

• Assisted the engineering team in developing products for surgical patient positioning, from concept to release• First-hand experience working with project management to organize documentation packages• Designed, documented, and performed verification and validation testing, and FMEA risk assessments

Cambridge, Ma, Us

• Designing, managing, and executing market research for biopharmaceutical and medical device clients• Translating client needs into effective research plans, analyzing data retrieved from plans, and presenting data on PowerPoint

Troy, Ny, Us

• Participant of the Louis Stokes Alliances for Minority Participation (LSAMP) Program (funded by the NSF)• Worked under Dr. Leo Wan at the Laboratory for Tissue Engineering and Morphogenesis• Experience with wet lab techniques such as cell passaging and fluorescent staining• Executed MATLAB script and utilized image processing, Image J, to determine cell chirality in multi-cellular patterns• Designed single and multi-cellular patterns on AutoCAD and LayoutEditor on silicon wafers for micro-contact cell patterning• Subjected cell patterns on gold-plated microscope slides to drug treatments with ion inhibitor pharmaceuticals

Master Of Engineering (M.Eng.), Mechanical Engineering

Bachelor Of Science (B.S.), Biomedical Engineering

Study Abroad