Mar 2014 – Jun 2024 · 10 yrs 3 mos · Utah, US

• Used the “Grief Energy” to create an infant mortality prevention device.
• Worked as one of the founders to create an infant monitor system for heart rate, SPO2, Skin temp, motion though an innovative Pulse Oximeter & sensors designed in a sock. Sock communicates with base station and thereon to smart phone app.
• Interfaced with Clinicians and researchers across the world and created medically sound paradigm.
• From concept through alpha, beta and final product. Engineering design (Software/hardware/firmware), QA-RA, Test and Human factors.
• Took product through full FDA compliance process (21 CFR 820 / ISO 13485, ISO 14975, AAMI HF), trained staff.
• As of 8/5/2015: Promoted from Vice President of Clinical Systems to Senior Vice President of Quality.
• Championed a safer product, when the existing product was hurting - causing burns on babies, in the face of severe opposition from an ill informed leadership.

Jan 2013 – Mar 2014 · 1 yr 2 mos · Greater Los Angeles Area

• Joined an ailing Fortune 500 Medical Device company (infusion pumps) with dynamic new leadership team.
• Infused a culture of cross functional collaboration, greater transparency & co-operation between teams in US, UK, Costa Rica, India & China, brought compliance to processes and procedures as laid down by leadership and Governmental agencies.
• Enforced process management, with focus on Six Sigma Lean techniques and configuration management to reduce defects / million to acceptable margins. Implemented cloud based information repository
• Built up a new team, with a new paradigm. Helped in successfully proving compliance per FDA Section 423 letters.
• Introduced new complaints handling, CAPA and product sustaining techniques (ISO 13485).
• Had to leave the company due to a personal tragedy which made me relocate.
• Responsible for 110+ people.

Mar 2011 – May 2013 · 2 yrs 2 mos · Yorba Linda

• Primary role in product sustaining. Worked with Patient vital diagnostics and care monitoring system. Wireless handheld minicomputer interfacing with Hospital Information system through HL7.
• Streamlining product development with VaVe and Agi-Lean processes. Brought new customer centric focus and introduced Human Factors engineering (AAMI HF).
• Brought effective resolution to major hardware issues with Honeywell (mini computer maker).
• Introduced risk analysis (ISO 14971), FMECA.
• Instrumental in helping acquire business with 2nd largest Hospital chain in the world.
• Responsible for 44+ people.

Jan 2008 – Mar 2011 · 3 yrs 2 mos

• Reports: 200, Budget $250 mil. Product: Cardiac Rhythm Management, MRI.
• Streamlined operations, Conflict resolution and collaborative team environment between Sweden, India, US.
• Created new structure and better alignment between engineering, marketing, Quality – regulatory teams.
• Created technical roadmap, architecture, design, prototype, test, supplier interfaces, manufacturing transfer/introduction and service support. Used SYSPRO ERP system.
• Led change through creative solutions to unstructured product design issues
• Refined & created leaner development cycle, reducing overhead costs by 18% for connectivity platforms using six sigma protocols. Fostered a culture of documented, data driven, decisions making, and the paradigm of gated development processes with extensive risk management.
• Implemented “Problems worth solving” company wide effort to
• (a) Unify architecture, reduce actual number of products but provide greater diversity in therapies.
• (b) Competitive analysis, market & technology analysis.
• (c) Implemented Human Factors & Usability paradigm in every program per new FDA “User risk and environment” in conjunction with device risk.
• (d) Introduced “Mock audits” for compliance.
• (e) Negotiated new standards with FDA as a member of Cross Industry expert panel.
• (f) Created new paradigm for MICS communication, and better power saving architecture w/ Zarlink Microchips.
• Implemented “Patient Peace of Mind” with 24/7 monitoring of patients and emergency response paradigm.
• (a) Merlin Mobile Cell phone created from scratch to read Cardiac implant, get emergency help. 32 new patents filed.
• (b) World first therapy for STEMI (Heart attack) which kills 600,000 people in the US every year.
• FDA 21 CFR 820 / ISO 13485 Quality system, ISO 14971 Risk management, AAMI HE75:2009, ISO 60601 Safety

Jan 2007 – Jan 2008 · 1 yr

• Reports: 100 Budget $56 mil. Product : Communication systems.
• As technical head & architect of system solutions for multiple platforms, designed highly reliable, fault-tolerant, extensible systems that led to creation of increased market penetration and growth
• Introduced effective data management (ERP) system for better interfacing engineering, PMO, sales and marketing. Coordinate resource assignment -prioritization including headcount & base cost budget. Syspro ERP.
• Utilized Six Sigma techniques for value stream mapping, takt time, ANOVA and Pareto analysis.
• Instilled a rigorous approach to target costing for new products and driving cost out of existing products. Notably: Reduced product manufacturing cost by 28%, by better ROI, Six Sigma, and a system for higher volume manufacturing.
• Established new business in India and Brazil. Entered a new market segment, by leveraging existing expertise and manufacturing capabilities.

Jan 2006 – Jan 2011 · 5 yrs

• Reports: 18 Budget $28 mil.
• Providing technical consultancy services for small to medium sized companies
• Spearheaded business development, personnel development and built infrastructure from ground up for a highly successful technical consultancy company
• Personally involved with:
• MIT (Massachusetts Institute of Technology) Plasma fusion center: Chief Scientist :Levitated Dipole experiment for Plasma generation.
• Irobot: Packbot and NeoMover infantry robots, R-Gator unmanned patrol vehicle
• Fractal Antennas: World first miniature, broadband, high gain, Omni directional antennas
• TVS instruments: Class 3 Medical implantable devices for cardiac, spine – neuro modulation products. PMA, IDE, 510k, V&V, 21 CFR 820, IEC60601 (safety), ISO13485 (quality) & ISO 14971 (risk management).

Jan 2004 – Jan 2006 · 2 yrs

• Reports 34 Budget $180 mil
• Business: Automotive Safety systems such as Tire Pressure Monitoring system (TPMS), Remote Keyless Entry (RKE), Body Control (CAN systems), Telematics : info-tainment, navigation, vehicle safety, fleet tracking, etc.
• Managed the Toyota & BMW portfolios, oversaw product sustaining and new development in collaboration with Michelin, EnTire & Honeywell and several international partners. Super high volume manufacturing.
• Managed a group of 34 people (hardware, software, firmware), with responsibility for several products manufactured at avg of 1 million units per design per year for 3 years. (Typical Automotive life cycle)
• Worked with six sigma, Toyota production system, DMAIC, SIPOC process management tools towards aggressively cutting on cost and improving quality. Ishikawa cause effect, Pareto, Value stream mapping, ANOVA analysis, etc.
• Participated in VAVE (Value added Value Engineering), FMEA, DFx, DFSS and other quality & reliability practices.
• Reduced cost of development of TPMS products by 12%, which is significant given mass volumes
• Created Telematics products for safety, infotainment, vehicle & fleet tracking.
• Worked with OEM’s and other Tier One suppliers in defining wireless standards for intra auto systems link
• Notable: Saved the Toyota Business by creating completely new product within record time of 3 months.

Jan 2001 – Jan 2005 · 4 yrs

• Technical consultancy with dedicated to take on the “impossible” challenges that our defense establishment faced with the post 9-11 scenario & upcoming war on terror
• Lockheed Martin Maritime Surveillance & Systems, Syracuse, NY: Aegis Radar Systems.
• Was inducted to Sigma Xi and IEEE MTT 8 as a result of ground breaking design.
• Tadiran Corp. Israel: Worked with developing DMR, MBMMR, and other radio systems.
• Cobham PLC, UK: Worked with developing Military Radio Tactical Command Digital Link (MRTCDL) for the army
• BBN Technologies, Boston, MA: Worked as a part of Boeing’s technical development team towards the Future Combat Systems (FCS) program, and mobile IP based agile comm. Systems
• NYSTEC, Rome, NY: Worked with the post 9-11 scenario to ensure crisis management and communication link was well established in NY state

Jan 1994 – Jan 2001 · 7 yrs

• Reports: 28, Budget $88 mil.
• Multinational company with its own line of products and providing services to several fortune 500 class 3 medical device companies. Joined as an Engineer and was eventually promoted to Sr. Engg Manager.
• Spearheaded a 28 member team (hardware, software, firmware) towards product development and sustaining product life cycle in diverse product families.
• Worked with international clients and partners, established clear information transfer, ERP, Six Sigma Protocols.
• Worked with global quality standards and driving forces, went through multiple FDA audits.
• Managed multiple in-house cross functional teams including hardware, software, firmware. Created technical roadmap, architecture, design, prototype, test, supplier interfaces, manufacturing transfer/introduction and service support
• Created new opportunities to leverage Supply Chain/Strategic Sourcing and Common Technology initiatives in the product line, Coordinated resource assignment and prioritization including headcount and base cost budget
• Worked with Verification & Validation, FDA design cycle, 510k-PMA, IDE (clinical Trials), Compliance with 21 CFR 820, IEC60601 (safety), ISO13485 (quality) & ISO 14971 (risk management).
• Performed hands on engineering design, test and verification