Create a third business at 180 Engineering for Consulting Services to fully complement the award-winning Contract Staffing and Direct Hire businesses. The Consulting Services will match mature and experienced technologists with key needs not addressed by the current consulting service market.☆ Recruit experienced individuals who want to make a difference with the 180 Engineering customers.☆ Assist in the talent discovery process to ensure all business needs are being met with… Show more Create a third business at 180 Engineering for Consulting Services to fully complement the award-winning Contract Staffing and Direct Hire businesses. The Consulting Services will match mature and experienced technologists with key needs not addressed by the current consulting service market.☆ Recruit experienced individuals who want to make a difference with the 180 Engineering customers.☆ Assist in the talent discovery process to ensure all business needs are being met with Consulting Services, Contract Staffing and Direct Hire.☆ Match very experienced consultants with businesses to address critical problems with focused and effective solutions.☆ Leverage the 180 Engineering vast recruitment experience in Aerospace, Automotive, IT, Manufacturing, Medical Device and Pharmaceutical industries to identify the very best consultant for a company’s particular needs. Show less

Create key area of new SAP system covering materials, bill of materials, documents, and change masters, enabling a compliant FDA implementation in SAP with full Device Master Record functionality.☆ Responsible for Master Data migration from legacy to S4/HANA in US and Switzerland.☆ Identify and modify quality processes to increase engineering efficiency and MDSAP compliance.☆ Analyze QMS processes, define design/testing and implement compliant SAP implementation with 0 defects.☆… Show more Create key area of new SAP system covering materials, bill of materials, documents, and change masters, enabling a compliant FDA implementation in SAP with full Device Master Record functionality.☆ Responsible for Master Data migration from legacy to S4/HANA in US and Switzerland.☆ Identify and modify quality processes to increase engineering efficiency and MDSAP compliance.☆ Analyze QMS processes, define design/testing and implement compliant SAP implementation with 0 defects.☆ Developed 30-step process and led consulting team to modify Base UoM piece-count in SAP Master data.☆ Analyze business impacts and lead the merging of SAP Master data via 3rd party software, SNP, in 200+ tables. Show less

Provide executive management for a naturopathic OTC medical product start-up, developing market/product branding, business and manufacturing plans, and business development for product distribution channels. Provide guidance on implementing CFR 21 Part 210 & Part 211 cGMP and an overall Quality Management System.☆ Set-up initial cGMP and QMS for production of contract and direct manufacture of homeopathic remedies.☆ Assist in the establishment of a cGMP-compliant manufacturing… Show more Provide executive management for a naturopathic OTC medical product start-up, developing market/product branding, business and manufacturing plans, and business development for product distribution channels. Provide guidance on implementing CFR 21 Part 210 & Part 211 cGMP and an overall Quality Management System.☆ Set-up initial cGMP and QMS for production of contract and direct manufacture of homeopathic remedies.☆ Assist in the establishment of a cGMP-compliant manufacturing production line.☆ Establish sales channel strategy and implement direct sales team. Show less

Energize small engineering team to deliver wide range of magnetic resonance imaging products and accessories. Deliver industry-leading MRI coils, gating devices, hearing protection and MRI compute devices following 21 CFR Part 820 Design Controls. Led team through multiple mission-critical product recalls. Enhance portfolio decision making process to evaluate product opportunities from a strategic and financial perspective while keeping resources optimized. Reduced costs of out-source resources… Show more Energize small engineering team to deliver wide range of magnetic resonance imaging products and accessories. Deliver industry-leading MRI coils, gating devices, hearing protection and MRI compute devices following 21 CFR Part 820 Design Controls. Led team through multiple mission-critical product recalls. Enhance portfolio decision making process to evaluate product opportunities from a strategic and financial perspective while keeping resources optimized. Reduced costs of out-source resources while increasing quality of deliverables.☆ Delivered 8 MR accessory products increasing sales by 28+%.☆ Grew the engineering team from 1 product team to 4 product teams in 6 months.☆ Successfully resolved four product recalls (pre-2015 products) without loss of customer confidence in products.☆ Released new product in 25% of time of historical NeoCoil product development cycles. Show less

Executive Management Consultant 2013 – CurrentProvide executive management for a naturopathic OTC medical product start-up, resolving past legal issues, securing venture capital, developing market/product branding, business and manufacturing plans, and securing business development for product distribution channels with on-line Internet sales, professional and retail sales.

Focused global product development teams on increasing profitability of portable X-Ray devices and delivered software that rejuvenated entire X-Ray portfolio. Created strategic plan to attack low-cost/premium and adjacent products in portable X-Ray market. Kept teams focused on value proposition and price points to hit financial targets. Assumed management of key suppliers and government accounts to improve quality and preserve contracts.☆ Launched 3 new products addressing key customer… Show more Focused global product development teams on increasing profitability of portable X-Ray devices and delivered software that rejuvenated entire X-Ray portfolio. Created strategic plan to attack low-cost/premium and adjacent products in portable X-Ray market. Kept teams focused on value proposition and price points to hit financial targets. Assumed management of key suppliers and government accounts to improve quality and preserve contracts.☆ Launched 3 new products addressing key customer deficiencies generating an 80% sales increase ☆ Identified 2 strategies by analyzing adjacent market spaces and secured funding for 2 industry-disrupting products expanding the portable X-Ray market by 30%☆ Led the formation and integration of a new supplier in Mexico for the delivery of a high-level assembly by the outsourced supplier to cut overall costs by 20%The US and India R&D teams included systems, imaging, software, firmware, mechanical and electrical engineering, and program management.☆ Revamped underperforming India development team by establishing a new management team to deliver a value portable X-Ray medical device for developing countries while meeting aggressive cost, quality and profit targets☆ Refocused a young global software team through process improvements and leadership changes to introduce new wireless detector technology resulting in $189M salesGlobal product support:☆ Established strategic U.S. government relationship allowing GE to create a unique military product and initiated DIACAP compliance project to allow the X-Ray business to preserve $22M sales☆ Formulated process and led the global licensing of UWB, WiFi and Zigbee in 200+ countries enabling the global sales new X-Ray portfolio☆ Instituted process for improving Trackwise investigations and reporting cycle time by 50% for FDA Accidental Radiation Observations (ARO), implemented CAPAs to reduce highest occurring AROs by 90%, and facilitated all ARO correspondence between GE and FDA Show less

Reinvigorated a system engineering team charged with system design inputs, and verification and validation under FDA 21CFR Part 820 design controls. Coached a frustrated team to embrace a radically expanded quality management system. Instituted global lean processes to greatly improve engineering practices amongst decreased staff.☆ Introduced effective program planning through detailed project management and scenario analysis allowing the medical device development team to meet… Show more Reinvigorated a system engineering team charged with system design inputs, and verification and validation under FDA 21CFR Part 820 design controls. Coached a frustrated team to embrace a radically expanded quality management system. Instituted global lean processes to greatly improve engineering practices amongst decreased staff.☆ Introduced effective program planning through detailed project management and scenario analysis allowing the medical device development team to meet commitment dates with high confidence and superior quality.☆ Revised the engineering delivery schedule through detailed project analysis for a product that slipped 1 year and held team accountable to a revised target date resulting in $142M of new product sales and outstanding quality.☆ Increased productivity of system engineering teams in India, China and France through standardization of processes, common roles and sharing of best practices during 33% staff cost reductions.☆ Implemented a prioritization process to efficiently utilize engineering resources while improving customer satisfaction with installed base.☆ Improved testing quality and coverage through the introduction of automated testing and distribute testing responsibilities in global design centers. Show less

Consolidated customer and requirements teams to reduce feature churn and to specify all feature content for $19B cellular portfolio. Collaborated with product teams to reduce cycle time for initial concept phase for cellular products.☆ Created a customer-focused team to interpret and negotiate future phone functionality with the top 12 global cellular companies and 35 internal stakeholder groups to optimize ROI and resources for new software releases.☆ Consistently achieved the… Show more Consolidated customer and requirements teams to reduce feature churn and to specify all feature content for $19B cellular portfolio. Collaborated with product teams to reduce cycle time for initial concept phase for cellular products.☆ Created a customer-focused team to interpret and negotiate future phone functionality with the top 12 global cellular companies and 35 internal stakeholder groups to optimize ROI and resources for new software releases.☆ Consistently achieved the highest marks in the cellular phone industry from customer report cards for front-end planning and requirements through precise analysis and dependable responses to customers’ requirements.☆ Established regional teams in U.S., China, Russia and Europe to reduce headcount costs by 10% and increased localized analysis of global customers in these regions. ☆ Delivered product requirements for cellular phones across multiple software baselines by creating a highly-effective matrix organization, and enhanced the development process creating consistent solutions across multiple product lines.☆ Improve requirements document delivery efficiency by 25% and reduce cycle time by 15% with no increase in budget☆ Enhance development process to create a single requirement document for four different operating systems ( Linux, Symbian, proprietary and ODM) with one common team Show less

Established planning group to construct software release for 60+ products through relationship building with multiple stakeholders. Created licensing strategy to improve profits and managed the outsourcing of smart phone development.☆ Constructed a prioritization process that allowed selection of top 7% of product features using business and technical criteria from a pool exceeding 1000 candidates.☆ Negotiated and controlled all third-party software contracts for smart-phone… Show more Established planning group to construct software release for 60+ products through relationship building with multiple stakeholders. Created licensing strategy to improve profits and managed the outsourcing of smart phone development.☆ Constructed a prioritization process that allowed selection of top 7% of product features using business and technical criteria from a pool exceeding 1000 candidates.☆ Negotiated and controlled all third-party software contracts for smart-phone development reducing product development cycle time through buying instead of building software.☆ Decreased IP licensing costs to 6% of sales instead of a projected 13% of sales through identification of valid IP claims and clarification of IP royalty calculations preserving approximately $56M in profits annually.☆ Define and prioritize software capabilities for all UMTS cellular phones in Japan and Europe☆ Create processes for negotiating UMTS worldwide customer specifications☆ Led effort for allowing Over-the-Air (OTA) updates of cellular phone software Show less

Created first set of 3G cell phone requirements that drove industry to today's smart phone configurations. Championed software processes as development teams were growing 400% and lacked sufficient process rigor.☆ Primary customer contact with NTT DoCoMo for technology and business discussions for the implementation of the world’s first 3G cellular service in Japan.☆ Analyzed initial Japan 3G cellular phone requirements and created initial software release plan for the development… Show more Created first set of 3G cell phone requirements that drove industry to today's smart phone configurations. Championed software processes as development teams were growing 400% and lacked sufficient process rigor.☆ Primary customer contact with NTT DoCoMo for technology and business discussions for the implementation of the world’s first 3G cellular service in Japan.☆ Analyzed initial Japan 3G cellular phone requirements and created initial software release plan for the development of industry’s first advanced technology cell phone.☆ Constructed feature estimation process for cellular phone software to accurately predict development resources.☆ Responsible for requirements generation and performance analysis for cellular phone software☆ Lead SEPG teams to define software life-cycle and requirements processes☆ Train global software development community (1000+) on software life-cycles (SDLC) and requirements Show less