Joe Bishop Email & Phone Number

Seattle, Washington, Us

Seattle, Washington, Us

Plans, directs and coordinates activities of R&D, manufacturing/operations; implements, supports and oversees organizational requirements, strategic planning and oversite for cross-functional team projects, communicates organizational objectives & results, formulates and administers organizational policies.

San Diego, Ca, Us

Serve as a member of the Executive Leadership team and provide strategic direction for all operational and research and development activities. Responsible for building and leading multidiscipline teams in the areas of operations, manufacturing engineering and R&D while creating a culture of innovation and operational excellence. Develop and implement a comprehensive design control / development process, project management teams utilizing cross-functional resources, departmental performance metrics/KPI’s and implementation of lean manufacturing principals. Development / evaluation of innovative and novel technologies for integration into the company portfolio. Responsible for corporate compliance with all applicable regulations.

Somerset, New Jersey, Us

Chief Operations Officer responsible for smooth integration of all company policies, developing long-range goals and objectives, and achieving all product / process development and manufacturing requirements. Managed process improvements to double production outputs, streamlined supply chain process to integrate with increased production demands and vendor lead-times to eliminate material shortages and production delays. Provided oversight and action plans for product portfolios, patent files, and research and development projects. Managed integration of all supply chain activities and consolidation of product planning and production scheduling. Directed all development projects and launch of critical access products for endovascular and urological interventional medical devices. Managed FDA and ISO Regulatory compliance activities including product submissions, regulatory audits and quality system compliance. Lead cross-functional project teams from multiple sites to develop / execute project plans, compliance activities, customer support, and sales and marketing strategies.Developed, negotiated, and executed related contracts, patent filings / office actions, distributor agreements and corporate partnerships. Planned and facilitated transfer of all products, operations and technical knowledge.

Developed an innovative medical device company that focused on first-in-class access sheath technology designed for multiple, minimally invasive clinical applications in cardiology and urology.Established lean manufacturing processes, operating policies and procedures, developed personnel and directed technical and business staff for key operational areas. Directed multi-disciplined teams of engineers, manufacturing, quality and regulatory personnel, ensuring each team is correctly focused, making the right contributions and delivering the expected outcomes to drive the business. Directed and managed deliverables for quality assurance, regulatory compliance and product submissions. Inventor of numerous issued US patents and published patent applications. Developed core technology roadmap and market valuations, drove finance and investment activities and managed discussions leading to acquisition.

Irvine, Ca, Us

Responsible for NPD / Engineering of innovative, minimally invasive endovascular stent grafts and delivery systems for the treatment of abdominal aortic aneurysms (AAA). Developed and expanded engineering teams and manufacturing personnel. Created departmental strategy, gap analysis and corrective action requirements; revised and implemented product design control requirements, created and implemented structure for enhanced departmental communication, develop product pipeline for expansion of core technology. Designed semi-automated processes and tooling for stent forming, established validation test requirements to satisfy FDA submission. Created and managed technical development strategies and project timelines. Initiated and managed project teams for development of bifurcated pulsatile fatigue testing and completion of R&D and Manufacturing module for successful PMA submission. Drove process for thorough and timely product complaint evaluation & CAPA compliance. Consolidated and managed patent portfolios.

Responsible for developing and coordinating departmental activities for Manufacturing / R&D / Facilities / Purchasing / Shipping & Receiving / Quality Assurance. Developed and implemented plans and objectives for product feasibility, design development and production for the RDX (Radioactive Balloon Catheter) System. Developed US and European manufacturing facilities. Designed and implemented bar coded distribution process and product logistics for Beta radioactive product. Implemented cost reduction activities that reduced final product cost by 50 percent.

Responsible for development and manufacture of products for the treatment of coronary and vascular diseases in the emerging field of vascular brachytherapy. Developed and managed teams for Manufacturing / R&D / Facilities / Supply Chain / Quality Assurance. Designed custom production equipment with radioactive shielding and established U.S. and European manufacturing facilities and distribution networks. Developed and implemented design control requirements from feasibility through product release for the RDX (Radioactive Balloon Catheter) system. Managed the implementation of lean and 5s manufacturing processes. Created bar coded distribution network and product logistics for radioactive Beta Source product, managed project teams for design and implementation of product labeling & database tracking systems and implementation of cost reduction activities that reduced final device cost by 50%. Completed due diligence activities and gap analysis for merger of Endologix.

Responsible for the engineering and manufacture of site-specific drug delivery catheters, combined angioplasty-drug delivery catheters, stent delivery catheters, stents and vascular access products. Developed and managed manufacturing engineering team and production personnel. Drove completion of departmental goals and objectives, developed engineering project plans / planned and coordinated manufacturing activities to produce high quality products and maintain effective finished goods inventories. Implemented and maintained QSR / GMP requirements.

Dramatically increased processing efficiencies, improved product quality and reduced unit costs by implementing lean manufacturing processes, creating InfoMap processing documents and established material Kanban and reorder points for efficient inventory control. Significantly reduced product and material WIP and adequately addressed material and product backorder issues. Designed semi-automated processing equipment and tooling, implemented qualification and validation procedures, supported transition of new products from feasibility / design / manufacturing.

Supervision of several manufacturing teams responsible for the fabrication of cardiovascular medical products for the treatment of arrhythmias, heart failure, coronary artery and peripheral vascular diseases. (Angioplasty catheters, guidewires, molded accessories, extrusions, guiding catheters and vascular stents), specialized in new product transition from R&D to manufacturing, developed and integrated new product designs / enhancements.