John Fischer Email and Phone Number

Glaukos Corporation- Developed and executed program management plans for implementation of enterprise-wide business process systems- Led change management through generation of operating procedures, project schedules, and communication plansRecensMedical- Developed and implemented strategic business plan to support US commercialization

- Provided leadership for global manufacturing operations aligned with company goals and strategies. Included supply chain and manufacturing activities in the US and China.- Ensured successful design transfer from R&D to Manufacturing in support of product launches.- Developed comprehensive, long-term Operations Plans to support company's 5-yr strategic plan.- Identified opportunities and implemented projects to decrease COGS through enhancements to bill of materials, manufacturing processes, and supply chain.- Provided Program Management leadership, including developing project schedules and reviews.

- Developed and implemented strategic objectives that improved the quality of life for our patients (spinal cord injury), reduced healthcare costs, and built shareholder value.- Led, planned, and executed product development activities (electrical, mechanical, software, and system engineering) for Class II and Class III neurostimulation devices.- Managed direct and third party manufacturing and supply chain operations.- Directed outsourced clinical, regulatory, and quality system activities.- Partnered with CEO, CFO, and Board of Directors on marketing, finance, human resources, legal, and investor/merger due diligence initiatives.

- Provided leadership and was accountable for overall project implementation for clients in the life sciences field, including pharmaceutical, biotechnology, and medical devices.- Client engagements included product development for novel medical technologies, business process optimization, FDA UDI regulations, and supply chain enhancements. Industries/Products include biotech cell culture media (Irvine Scientific), diabetes care devices (Abbott Diabetes), combination drug delivery devices (Amgen), and endovascular/cardiovascular catheter stent systems (Abbott Vascular).

- Directed 1st generation S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) program from early R&D stage, through CE Mark clinical study/design dossier submission, IDE clinical study/PMA regulatory submission, and European/US commercialization.- Responsible for high profile program to enable the 1st generation system design to scale with manufacturing operations ramp-up activities in support of full US and global commercialization launches that resulted in over $100 million annual global sales revenue.- Partnered with fellow executive team members on corporate governance activities, including enterprise objectives, annual operating plan, strategic planning, product map, and acquisition integration.- Created, managed, and executed the Program Management Office (PMO), including defining PM processes, hiring/developing project managers, and tracking the progress of all projects.- Led design control, project planning, project management, project documentation activities.- Created and oversaw Project Portfolio Management (PPM), including project intake, project prioritization, resource planning, portfolio status communication.

- Directed multiple mission critical programs that successfully delivered medical device products (Pacemakers, Implantable Defibrillators, Programmers) from the early R&D stage through to global market launches. - Included up front Voice of Customer and Human Factors activities, as well as the management of electrical, mechanical, software, and system engineering development projects, clinical studies, and regulatory submissions across multiple company sites throughout the US, Europe, and Asia Pacific.

- Managed Pacemaker/Implantable Defibrillator Programmer product line, including an international cross-functional team of engineers, technicians, manufacturing operators, and supply chain personnel.