Mike Wolniewicz Email & Phone Number

Kalamazoo, Mi, Us

- As a member of the senior leadership team, initiate and execute on business strategy.- Provide leadership and management for research and development of NPD programs and activities to execute product pipeline.- Manage and develop technical capabilities in alignment with strategic planning and business needs.- Ensure Design Control requirements are established, maintained, and adhered to.- Interact across business unit to facilitate NPD execution and successful product launch and commercialization.- Develop improved methods and frameworks to drive efficiency and capacity for R&D activities.- Implement and maintain company R&D procedures, reporting on performance and initiating improvements across NPD.- Vendor selection for R&D activities and product scale up.- Manage and support process and product transfer and scale up.- Work with external parties relating to procure services and materials for company R&D activities.- Manage the development of new product lines, increased turns, expansion of existing product lines, and continuous improvement in existing product lines.- Facilitate recruiting, development, and structure of the R&D department.

Seattle, Washington, Us

Developed and implemented business and technical strategy as a consultant for nine months prior to being recruited by company founders to join full time.- Organized and executed product pipeline for new products.- Optimized and implemented metrics for predicting and improving product performance.- Identified and developed key vendors for high volume production scale up activities.- Provided input on business development activities.- Communicated proposal planning, deliverables, and execution with co-development partners.- Initiated and applied DFM/DFA to existing and new products.- Managed rapid prototyping and testing.

Led a technical team of engineers and technicians responsible for all catheter-related R&D and sustaining engineering activities. Directly supported a $120M+ intravascular catheter product line. Delivered customer-focused products through cross-functional team management across departments and company sites.- Developed and implemented corporate Engineering strategy and plans, including pilot production, next generation devices, and support of device transition from limited to high volume manufacturing.- Communicated corporate strategy and goals to Engineering and Facilities staff.- Managed multiple projects in accordance with agreed budgets and timescales.- Lead the Engineering staff in developing a Lean Manufacturing environment. - Lead the Engineering staff in sustaining engineering and facility improvement activities.- Managed Engineering staff according to company standards (appraisals, discipline, training, development, etc).- Developed outside OEM services to support production scale up initiatives.- Liaised with key opinion-leading physicians.- Provided planning and technical support for clinical trial execution.- Provided technical expertise to maintain critical supplier relationships.- Lead the Engineering development of all suppliers to support production and quality objectives.- Presented progress updates, plans, budgets, and training to Senior Management.- Provided executive policy and strategy.- Expertise in GMP, ISO 13485, MDD, and QSR requirements.- Utilized DFM/DFA, DoE, CAD, SPC expertise.

Redmond, Wa, Us

Co-invented a patented innovative tissue-fixation device and surgical technique. Completed all phases of the product development life cycle, from concept, design, and manufacturing through clinical trial enrollment.- Planned and executed product design verification and validation activities.- Prototyped innovative device concepts and developed unique manufacturing processes.- Worked with supply chain leads to identify and develop key suppliers.- Fabricated clinical use devices and participated in first human clinical device usage.- Authored and released documentation such as mechanical drawings, test reports, bill of materials, and assembly instructions.

Managed engineering team activities and processes; executed device feasibility and development; established initial manufacturing line and processes; provided onsite technical support for international clinical device trial; invented and qualified unique device test methods and apparatus.- Authored and executed process validations (IQ, OQ, PQ) and validated inspection methods for verification and process controls.- Developed and executed device reliability testing protocols.- Performed Design of Experiments (DoE) for process definition and equipment parameter optimization.- Fabricated clinical use devices and participated in first human clinical device usage.- Communicated project status to all levels of leadership, including performance, cost, and schedule updates.

Mba, Business Administration

Bsme, Mechanical Engineering