Mark Oldakowski Email & Phone Number

San Diego, Ca, Us

San Diego, California, Us

Leading the development and production of instruments, assays, consumables, software and bioinformatics. Applying Bionano's unique capabilities to the study of DNA Structural Variations as they apply to human disease and evolution.

Chelmsford, Ma, Us

Created and managed a $10M multinational engineering organization. Developed and sustained products for life science and clinical markets, including automated temperature and atmospherically-controlled storage and retrieval systems, high throughput screening solutions, nucleic acid analyzers, bench-top automation and consumables.- Supported growth of life science business from $11M to $60M by re-architecting key product lines, creating custom design solutions and using off-shore resources.- Initiated and maximized use of 3rd-party off-shore resources to support internal design teams, achieving 20% utilization rate across all functions.- Led consolidation and re-architecture of the top revenue-producing technology platform that contributed to 95%+ of business wins since introduction in 2013.- Served as a key customer contact to ensure new product development and sustaining activities met expectations.

Santa Clara, California, Us

Managed a $4M, 10-person engineering organization. Developed life science instruments for processing and imaging of genotyping and gene expression ‘peg arrays’. Instruments were comprised of robotics, fluidics, thermal control systems, automated CCD-based fluorescence optics and tip-tilt controls.- Leveraged various consultants and multiple contract design firms thereby reducing development costs 20%.- Launched 2 systems; 1 low-cost, low-throughput; 1 high performance, high throughput. The latter became the standard high throughput genotyping platform for disease association studies around the world. Integrated Assays and Workflows onto the systems.- Initiated, socialized and led multi-functional, cross-company initiatives in resolution of product and process quality issues related to legacy products. This resulted in tangible reductions of out-of-the-box failures (50%+ improvement) and enhancements in mean-time-between failure of 200% of a key system in a $100M product line.

Forchheim, De

Oversaw 30 engineers and 10 international contractors in executing laboratory automation projects involving 510Ks.- Led multiple simultaneous projects individually and through subordinate project managers per the IVDD and FDA’s QSR regulations. These resulted in Laboratory Automation System (LAS) products used in core labs.- Applied use of off-shore software resources that enabled additional parallel projects.

Waltham, Ma, Us

Directly managed a staff of software / firmware engineers and coordinated work of multiple international consultants. Oversaw $2.5M annual budget and an average of 3 projects. Served as a Project Manager on key Programs. Supported DNA sequencing and real time PCR products.- Led development of 2 life science instruments starting at feasibility. These were multi-million dollar cross-functional projects with durations of 1 and 2.5 years, respectively. Led teams of 30+ personnel, including assay integration. Utilized DFSS including critical parameter management.- Led development of OEM software per FDA QSR regulations used in manufacture and service of a medical device. This $3M project had a 2-year duration from feasibility to commercial release. Team consisted of 10 engineers at multiple international locations. Software passed multiple internal / external QSR audits- Developed automated tools for testing life science instruments (PCR, Real Time PCR, DNA Sequencers) that were an integral part of the quality chain, from vendors to manufacturing and field service.- Initiated use of engineering resources and vendors at international locations resulting in increased group capabilities and cost savings of 25% to 40% per FTE resource.- Integrated off-the-shelf and custom hardware / software in rapid prototyping environment that reduced time to prove concepts 30% over previous custom solutions.- Created and implemented development process compliant with FDA QSR regulations for use in developing software for testing medical diagnostic devices.

Waltham, Ma, Us

- Led a team in the development of software for engineering, manufacturing, and field service for an array-based fluorescence reader.

Waltham, Ma, Us

- Served as the techincal lead responsible for specifying, designing and implementing the embedded systems for automatic and manual nucleic acid extraction and purification instruments.

Waltham, Ma, Us

- Led the test software development efforts of a PCR sequence detection system, various robotic sample preparation robots, and an integrated thermal cycler.- Served as the lead manufacturing engineer supporting a robotic liquid handling system.- Authored guidelines for the development of software and test hardware for manufacturing.

Meng, Systems Engineering

Bs, Electrical Eng.