Michael Delk Email & Phone Number

Texas, United States

Austin, Texas, Us

VP/GM leading North American design & engineering organization for Flex Health Solutions $2.5B medical device business unit.

Somerset, Nj, Us

Member of Executive Leadership Team responsible for leading the corporate R&D team and technical oversight of all new products/platforms, technologies and manufacturing processes. Includes building and growing a dynamic global R&D organization with responsibility for Prototyping, Design Engineering, NPD/Program Management, Process/Technology Development, Automation and Manufacturing Transfer.Directly responsible for managing a $50MM NPD portfolio; established and chaired R&D Steering Committee and developed and implemented Portfolio Management and Analytics methods, KPI’s and metrics, and Sales-to-NPD funnel.Transformed 45+ member R&D organization to meet emerging business needs and to drive growth for next decade by increasing department throughput and revenue stream from $1.5MM revenue (<2% overall company revenue) in 2012, to a projected $8.5MM+ revenue (7.5%) and $1MM profit for FY18. R&D CAGR is 3.5X the overall company CAGR. Member of Executive Commercialization committee responsible for developing company sales and business development strategies focused on program technical feasibility evaluation, alignment to corporate strategic goals and impact on company operations.Represent the company technically in its relationships with major customers, suppliers, etc. including engagement and development of joint R&D relationships with Tier 1 Global Medical Device companies.Participate in Executive management and business process forums to form company policy, develop strategic plans, technical road maps, capital spending plans, quoting/proposal development, S&OP and action plans.Strategic program oversight for development of surgical robotics and digital surgery platforms, including a first to market digital surgery platform. Additional example product experience includes stapling devices, hernia repair, urological, biopsy, diabetes monitoring, reusable and disposable laparoscopic instruments, and energy devices.

Franklin Lakes, New Jersey, Us

Promoted to member of Sr. Leadership Team for a $1.5B division responsible for establishing current and long range strategic NPD portfolio, growth (organic/inorganic) & innovation strategies, operating budget, and recruiting and professional development. Direct staff of NPD Program/Project Managers, GPDS Manager and System Administrators responsible for planning, managing and executing portfolio of projects from concept thru commercialization. Directly responsible for managing a $350MM NPD portfolio, including the overall technical direction, coordination, implementation and phase-gate execution of global projects. Represent the company as appropriate in its relationships with major customers, suppliers, etc.; development of joint R&D relationships with top 5 global Diagnostic Instrument companies, and user needs evaluation and application analysis with major reference labs (Quest, Labcorp).Responsible for portion of Annual Strategic Review document (5-year plan) outlining NPD plan, Product and Technology Maps, project pipeline, resource analysis, spending plan, and commercialization/financial expectations. Responsible for developing and managing $30MM+ annual R&D budget including Innovation, R&D, Clinical, Advanced Mfg. Engineering and Life-cycle Management.Managed the development and expansion of the Division's intellectual property assets; involved in Leading Growth & Innovation (LGI) corporate initiative to drive innovation deeper into the organization. Recipient of 2011 BD Corp IP Award.Chair of NPD Portfolio Decision Team and member of Corp GPDS Leaders Committee responsible for establishing corporate NPD policies and procedures. Developed Portfolio Management & Analytics procedures and tools to ensure robust pipeline supported by data-driven metrics (Milestones >90%; Budget +/-10%; Portfolio NPV >$300MM; Portfolio 10-year Incremental Revenue >$1B).

Franklin Lakes, New Jersey, Us

Responsible for leading a global NPD platform team comprised of NPD Program/Project Managers, Marketing, Quality, Regulatory, Advanced Process, Lifecycle Management and Finance. Program oversight and responsibility for planning, managing and executing portfolio of projects from concept thru commercialization including operating budget, program recruiting and talent management. Created a new NPD strategy & approach by driving Project Managers to be responsible for business outcomes, not just project execution. Provided training in market analysis & commercialization tools (GMPH), critical thinking, and Health Economics and Outcomes Research to establish solid value propositions for all new products in pipeline.Foster KOL development and established relationships with clinical thought leaders; developed relationship with global hematology expert within The Charite (largest hospital group in EU) resulting in Charite participation as an NPD alpha site, clinical trial site (multi-center), secured tender for BD as a sole supplier and clinician as member of BD Scientific Advisory Board.Directed select top-tier global project team responsible for supporting divisional global market expansion in underdeveloped and emerging markets, incl. front-end opportunity assessment, market segmentation, user needs analysis, market development requirements, global device development, and manufacturing site selection.

Plano, Tx, Us

Reporting to the CEO and President, responsible for formulating corporate direction and strategic vision, operational plan, growth strategies (including organic growth/licensing/joint venture agreements), capital and operating budgets, and the recruiting and development of human resources. Directly responsible for planning and directing NPD efforts as well as advanced manufacturing engineering in support of company goal to increase cash flow and EBITDA. Built group from initial sustaining engineering focus to NPD/Advanced Process group working with recruitment professionals and industry contacts to establish a high-level department capability.Authored and implemented an ISO 13485 compliant Design Control System; successfully completed an FDA site audit and multiple KEMA recertification audits. Heavily participated in all audits.Added Advanced Manufacturing Engineering department to NPD group to concurrently develop, validate, and transfer processes to manufacturing as part of product development project teams.Implemented and Chaired NPD/VIP Project Steering Committee and developed training programs in project management, team dynamics, regulatory compliance, Design Control, and Intellectual Property.Added Packaging Engineering department to NPD group to support project teams, identify cost savings opportunities, and automate labor-intensive packaging operations.Managed development of a Hydrophilic Guidewire (Cordis Aquatrack) which generated a top-line revenue increase of 12.5% for the company in its first year of sales. Product represents the top-selling Argon offering .Directed cost savings projects worth in excess of $1M annually. Identified $2.7M of ongoing process improvement/cost savings projects for future implementation.Developed product line in new market segment by leveraging existing product line with product modifications to enter Endovenous Laser Treatment market. This market now accounts for two out of the top five Argon customers.

Responsible for all aspects of development operations including program management, design engineering, business development, financial management, staffing, project proposals and contract negotiations in privately held company engaged in product design, development and engineering of medical devices from concept through manufacturing transfer. Provide strategic planning leadership by meeting with surgeon thought leaders, anticipating industry trends, and applying emerging technologies to disease state management. Increased initial staff from 3 to 9 direct reports engaged in industrial design, product development, program management, design engineering and manufacturing. Led engineering team responsible for transferring electromechanical medical device manufacturing line, processes, tooling, etc. from Mainland China manufacturer to Mexico manufacturing site without incurring any interruption in sales or missed shipments. Involved in major development programs for large medical device companies such as Johnson & Johnson and C.R. Bard as well as established development relationships with small entrepreneurial start up companies.

Providence, Ri, Us

Recruited by principals to add Class I – III medical device product development and engineering capability to existing consumer and children’s products design firm. Responsible for all aspects of starting up and managing the medical/technical businesses including initial staffing and training, administration, program management, sales, business development, as well as directing operations of medical manufacturing division in China. Involved in a wide range of development activity across many specialties with products ranging from single use disposables to embedded software electromechanical products.Expanded development activities into speculative new product ventures consistent with business segment strategy resulting in OEM manufacturing and royalty licensing agreements.

Murray Hill, New Jersey, Us

Responsible for all new major development programs in multiple surgical specialty product lines, overseeing project managers and multidisciplinary development teams working in orthopedic, laparoscopic, endoscopic, and wound management device areas. Conceived and championed the implementation of a global manufacturing strategy in an effort to contain product costs which led to companies first-ever international technology program utilizing domestic and Hong Kong based engineering teams and Chinese manufacturer which resulted in construction and start-up of Class 10,000 medical clean manufacturing site in Shenzhen, China. Member of team charged with creating and implementing Portfolio Management Process to control and direct the divisional product development activities and allocate appropriate resources to each development effort. Fostered an environment of creativity and innovation in completing divisional and cross-functional business unit responsibilities. Actively managed intellectual property portfolio. Led team responsible for integration/assimilation of Laparoscopic Products Div. product lines and NPD programs into Surgical Products Div. business during the merger of two divisions.Prepared development strategy for 3 year Strategic Business Plan, including developing long term plans for technical staff, aligning the project activity and business strategy, and ensuring that departmental expense budgets including staff/facilities expansion plans and capital budgets meet all business unit and divisional responsibilities. Interfaced with marketing, sales, and manufacturing to identify new products and systems in support of short/long term business strategy and developed appropriate business models to bring technologies in-house.Chaired roundtable discussions at key physician conferences on new product and surgical techniques to help identify key thought leaders for joint development activities.

Chemical Engineering

Mba, Management/Intl Business

Pharmaceutical Chemistry/Chemical Engineering