Site Head of Engineering Operations

**Company Overview**

Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis. The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally simplifies it for providers. Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by anyone. The integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission and a proprietary data analytics platform powering a new holistic approach to dialysis care.

**Position Overview**

The Site Head of Engineering Operations will lead a team of engineers, technicians and facility team members to develop and improve upon the existing manufacturing equipment, processes, testing strategy and maintenance of capital dialysis equipment. This manager will also create the strategy and roadmap for automation of test fixture and manufacturing processes to ensure manufacturing scalability as the company continues to mature. Using analytics, they will help support and execute change orders to continually drive and develop Manufacturing 4.0 concepts to maintain a competitive advantage within the market space. The Site Head of Engineering Operations is also responsible for growth and development of their team members to ensure redundancy of critical roles & responsibilities while also highlighting key contributors for internal growth possibilities. He/she is also responsible for cascading of corporate milestones, initiatives, and goals to their team members in the form of managed projects with proper resource allocations. This position will also provide input to business models to justify manpower, budget, space, and capital requirements.

**Essential Job Functions**
- Create and develop a team of engineers, technicians, and facility members to provide tactical and long-term strategic support in the areas (but not limited to):

- Troubleshooting
- Test Fixture design
- Automation of manufacturing processes
- Integration of Manufacturing 4.0 concepts and IoT sensors
- Develop, manage, analyze, and improve (PDCA) on KPIs related to FPY, RTY and other manufacturing metrics.
- Develop and implement an engineering roadmap that ensures scalability for manufacturing processes as well as improvements in FPY.
- Determination of resource allocations and needs for successful support and growth of current and future products.
- Creation and support of Change Order implementations for continued improvements.
- Participation in Kaizen and other LEAN and Six Sigma concepts to facilitate transformational growth at the site and corporate level.
- Development of yearly and quarterly goals for department and team members that align with the corporate initiatives and cascading goals.
- Development and leading of team and team members to generate and sustain internal growth opportunities for capable and driven team members.
- Development and support of manufacturing aids and tools to help in improving and maintaining product quality.
- Development and execution of Master Validation Plan and items related to such plan.
- Development and maintaining of engineering tools and manufacturing aids spare parts.
- Establish and sustain strong culture of accountability and data driven decision making processes.
- Implement standard operating procedures for production; ensure standards are met and analyze production and quality controls to detect and correct manufacturing problems/concerns.
- Assist with creating/maintaining budget and provide return on investment (ROI) analysis for select capital expenditures.
- Deploy concepts and tools for root cause analysis to ensure fast response to manufacturing issues.
- Participate in internal and external audits to ensure compliance with quality management system.
- Interact and collaborate with individuals from across the organization to help support in areas such as (but not limited to):

- Material specifications/dispositions
- Manufacturing Troubleshooting
- Customer support and success
- Ensures product is built to specifications and within FDA/cGMP, ISO, and all QA requirements.

**Requirements/Qualifications**
- Requires a bachelor's degree in an engineering discipline (Electrical, Mechanical, Robotics or a combination of them).
- Minimum 10 years related work experience in manufacturing with at least 7 years of managerial responsibilities.
- Experience in building, developing and leading people.
- Experience leading cross-functional mission critical systems infrastructure and programs.
- Experience working in a regulated industry-Medical Device, Pharmaceuticals or Aerospace.
- Experience in data analytics and decision making based on analytics.
- Demonstrated experience