Overall owner of product design, development and commercialization in support of the firm’s growth strategy. Lead and own product development initiatives, product launch strategy and execution, and market intelligence gathering that impacts product development priorities.Was Vice President, Engineering, August 2023 -January 2024

Product portfolio includes flagship Automated Laboratory System (Merlin) to disrupt the central-lab diagnostics model combined with proprietary silicon-photonics sensor diagnostic system (Maverick) and a clinical-to-EHR integration software system.

Spearheaded multiple cross-departmental product and process improvement programs including: MFG equipment and processes for cost and yield, material performance and cost reductions through supplier evaluations, realigned hardware design and assembly documentation to ensure V&V readiness for FDA submission, restructured Software design control process including cloud-client SDAD architecture from a technical audit to enhance capabilities, and helped guide Maverick program to the V&V timeline. Supported the development of 3 cross-departmental direct and indirect reports in defining goals, identify skills and education opportunities, and cultivate a positive work environmentImpact includes:• Decreased software timelines by 80% (6 months) meeting company critical timelines. • Resolved outstanding Hardware instrument designs, drawings, and assembly docs of flagship product for 510K V&V readiness and FDA compliance.• Increased manufacturing yield to 95% in 6mo, increased throughput by 5%, and reduced product cost by 15%

After senior management staffing crisis, I was entrusted by executive team to become Head of Quality - reporting to CEO - concurrently as Director of Development.Improved Quality mindset across organization. Managed NCRs, CAPAs, product issues, and internal audits to meet FDA 21CFR820 cGMP and ISO 13485:2016 compliance regulations. Defined and evaluated Software Quality for EPICs, SDAD, User Stories, Defect analysis and disposition, GxP / SOUP / OTS analyses. Ensured V&V studies for FDA submissions were compliant. Implemented Product Quality initiatives by establishing Quality Metrics. Managed 10 people in Quality and Software Test teams to prepare schedules, assign targets, identify underperformance, and cultivate a positive work environment.• Successfully led the company through an ISO13485 surveillance audit with 2 week notice. • Defined required activities and coordinated company through a simultaneous facility relocation and System V&V studies for FDA submission of the thermal-upgraded Maverick System and multiplex-assay.• Identified Clinical software shortcomings. Supervised SW engineers and quality teams to identify, resolve, and revalidate several apps in 2 months.

Global IVD and Life Science contract design and manufacturing organization (CDMO). (Acquired by TE Connectivity, 2020)Technical Lead and Program Manager for IVD product development from conception to FDA submission. Started with evaluating user needs to create requirements, risk assessments, and project plans. Managed budget, schedule, quality, risk, team resourcing, procurement, and client communication. Co-wrote grant applications for BARDA, SBIR, NIH, HHS, and US Department Energy. Technical Sales (Business Development): Analyzed client technology and product vision for viability, prepared risk-mitigated development strategy proposal to achieve FDA submission including resource needs with cost and timeline estimates. Wrote industry relevant blog entries, produced webinars, and presented at national and international conferences. Involved in M&A and technical due diligence of multiple acquisition targets to create TE IVD solutions.• Managed over 50 global diagnostic and life science product development programs from concept to FDA submission, leading multi-disciplinary teams in delivering innovative IVD solutions.• Drove product strategy development, aligning engineering, quality, and regulatory functions to meet client needs while reducing development costs by 20% and improving time-to-market by 25%.• Co-wrote successful grant applications, securing $350M in VC funding and FDA clearance for 7 products.• Promoted to Senior Program Manager Engineer for dedication and commitment to work excellence after acquisition.Technical Expert for: integrating bioassays, microfluidics, fluidic handling, on-board reagent storage (lyophilized or liquid), material sciences and bonding methods, consumable design and instrument interfaces including DFX integration, user interfaces for CLIA-waived devices, and manufacturing engineering and process development.

Same role as my promoted position: Senior Project Manager Engineer

Infectious disease diagnostic using DNA/RNA detection and cyclic-voltammetry where sensitivity was defined by increased gold electroplated surface area of the “Aura sensor”.Performed an Operations and Quality review of product capabilities against corporate goals. Proposed in-sourcing product development and manufacturing. In 6 months, Installed a pilot manufacturing line and ISO 5/6 combo clean room with full supporting equipment on top floor of a high-rise in downtown Toronto. Within a year of installation, reduce consumable costs by 80% and achieving a throughput of 7,500 units/month with a 95% acceptance rate in time for clinical trials

• After 483 warning letter, identified root cause of elevated variability through statistical analysis of flow rates on >1000 devices which validated manufacturing and material issues and justified development of a pump-controlled TRIAGE device. • Improved TRIAGE Drugs of Abuse yield by 23% by developing an improved cut-off algorithm.

Designed and validated a new manufacturing line for a combination immunoassay-electrochemical heart failure diagnostic platform, achieving a production rate of 1,000 parts/hr with high precision.

Pre-funding. Prepared marketing, product development, and sales strategy documentation detailing how Segmentation Engine software product impacts patients with significant improvements in medical image analyses for tumor radiation planning. Won $750k in funding in November 2010.

(Now Axela http://www.axela.com)