Building highly motivated team of engineers in the areas of sytems, risk, human factors, user experience, lead designer, biocompatibilityDeveloping innovative products in the areas of Electroencephalography, Polsomnography, electromyography and neuro critical careManaging Natus engineers, contract engineers and contract manufacturers.Providing input for strategic planning, budgeting, closing CAPA’s, providing audit supportDeveloping AI/ML models to assist clinicians in diagnosing Electromyography (EMG) disorders

I lead a team of twelve associates to develop design history files of four medical device product lines to complyto EUMDDR regulations in 12 months.I made technical decisions to meet efficacy, safety, compliance, and design controlsI managed a team of 9 engineers for design, development and manufacturing

Developing and managing medical product requirements, executing usability , formative and summative studies, leading product development team, applying problem solving methodology for robust solutions, leading projects from market research to approval for development and innovating highly usable products.

• Increased production capability by 100 % and reduced backorder to zero by leading a global team of engineers and suppliers to build a capable manufacturing line.• Increased factor of safety by 90% through corrective and preventative actions (CAPA)• Developed 9 concepts for reducing device cost 30% resulting in an annual savings of $1.5 million through the application de Bono lateral thinking and TRIZ.• Reduced the time to develop equipment 50% through the application of Design of Experiments (DOE)• Engaged resources 30% faster by developing requirements cascaded down to the part level at early stage. It engaged operations, quality, regulatory and supplier management.• Doubled the manufacturing capacity of 2nd highest selling product by validating equivalency of devices produced by new line with those from existing line. It required a sound sampling plan, measurement system and statistical analysis.

• Developed a differentiated device combining RF and ultrasonic energies by developing a unique test bed, test plans, design of experiments (DOE), automated data collection, statistical analysis, presentations and written reports.• Mitigated risk by automating 75 % of surgery steps through algorithms in the software and extensive use of Solidworks, Matlab and Minitab and Abaqus.

Designed a device to enter into spine surgery market by designing an ultrasonic device in a differentiated way.• Increased the design limits of the past by 15% through advanced mechanical analysis, resulting in entry into orthopedic market.• Increased a factor of safety 25% in meeting IEC60601 through rigorous pursuit of quality plan based on Quality System regulations (QSR) and ISO 14971 early in the design.• Created device for spine bone surgery, adding safety for nerves in operative site, achieving performance matched of gold standard, and expecting bridging of gap in portfolio of DePuy and reducing competitive threat.

• Designed device to deliver power in half the size of predecessor, becoming a gold standard in Thyroidectomy and capturing 45% of market share in 3 years and achieving $300 million in revenue.• Reduced the PZT transducer design time 50% by automating Abaqus Finite element analysis. • Launched the device within 15 % of predicted time and cost by applying PMM tools, latest metals, plastics and manufacturing technologies. • Reduced verification and validation time by 25% by writing well targeted test plans, measurement system GR&R greater than 30%, parts capability (Cpk) greater than 1.33, communicating results in written reports and audience appropriate presentations.

• Developed 15% longer ultrasonic device for obesity market that was impossible to achieve by applying critical thinking skills, de Bono lateral thinking, and TRIZ methodologies for outcoming insurmountable hurdles o Applied virtual DOE’s to quickly converge to optimum design and creating virtual DOE best practice for device designs.

• Eliminated barrier to markets by designing an ultrasonic transducer of a reduced form factor by increasing efficiency 25% so that air cooling was not necessary.• Enhanced R&D capability by mentoring and coaching 9 engineers in ultrasonic transducer design. • Automated half of the tedious design steps with the application of piezo-electric software, Abaqus for finite element analysis, Minitab for statistical analysis, and Solid Works for CAD designs.

• Eliminated barrier to markets by designing an ultrasonic transducer of a reduced form factor by increasing efficiency 25% so that air cooling was not necessary.• Enhanced R&D capability by mentoring and coaching 9 engineers in ultrasonic transducer design. • Automated half of the tedious design steps with the application of piezo-electric software, Abaqus for finite element analysis, Minitab for statistical analysis, and Solid Works for CAD designs.

• Improved quality of acquired UltraScision products, reducing customer complaints by 50 %.• Mentored and educated Ethicon engineers in new technology, which enhanced organization capability and launched twice the number of products in same duration.

• Directed engineers of new acquisition, UltraScision, bringing 3 significant designs to completion.• Guided engineering talent transition from home base to Cincinnati, resulting vital knowledge transfer.• Applied ultrasonic technology for entering in plastic surgery.

Development laser based devices to treat tissues endoscopically. Identifying new product opportunities based upon clinical results and competitor's products.Launched a Urology product in six months from concept with a revenue expectation of $1 million and ancillary product opportunities of $5 million.

• Lead teams to develop ophthalmic surgical devices. •Developed a laser based cataract emulsification device, •Working with surgeons developed feasibility devices •Developed and launched a hand piece to drive various cutting devices for the anterior surgery. It is targeted to increase the profit margin from 15 to 250 percent, eliminate customer complaints and reduce warranty costs by 95 percent. Developed a design and a process to make the phaco emulsification device more robust, brought performance within tighter specifications, reduced warranty and manufacturing costs. Organized and led teams to find root cause of the chronic problems with various products.

•Provided competitive edge to clients by offering market niche product concepts and product development services. •Prepared, sold and delivered on product proposals to major medical device companies. •Performed engineering analysis of orthopedic drill, which helped to resolve short and long term field failure problems. Applied finite element analysis and root cause analysis. •Performed engineering analysis of a surgical stapler to determine product robustness, reliability and functionality. •Applied Design for Manufacturability knowledge. •Developed concepts for improved cardiac catheterization. •Applied concept generation skills. •Developed concepts for reliable continuous blood pressure monitor. •Developed a concept and feasibility prototype, which increased pumping efficiency from 20 to 40 percent and reduced hemolysis.