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.
The Product Support team is the primary technical liaison between Outset Medical’s internal technical groups (Engineering /Quality /Manufacturing) and the Field Service, Technical Support, and Service Operations teams supporting the product. With the development and introduction of new products or software/hardware updates, the Product Support team coordinates the deliverables and timelines to ensure the customer support teams are prepared for launch. For commercialized products, the Product Support team is a tier three escalation support group, and is responsible for improving troubleshooting techniques, service documentation, and product/process.
The success of the Product Support team is mission critical to the success of the Field Service and Technical Support groups. This is where your hands-on experience supporting global service organizations, your fascination with technology, and your passion for leading change within a complex, fast-paced, highly regulated environment can make a direct impact.
Essential Job Functions and Responsibilities
- Oversees the planning and implementation of new product introductions and upgrades/recalls on behalf of Service, ensuring appropriate planning, communication, and service readiness in alignment with product development and commercialization target dates
- Integrates with Engineering during product development cycles to drive hardware and software service requirements upstream to Engineering, directly impacting product design and the ability of service organization to efficiently install, troubleshoot, repair, and maintain the product
- Serves as service representative on Design Reviews for design and commercialization phase reviews
- Responsible for the creation and maintenance of all product installation and service documentation in compliance with Regulatory and Quality standards
- Ensures team readiness to support tier 3 escalations from Technical Support, drives resolution of technical issues through engineering
- Maintains subject matter expertise with respect to the servicing and maintenance of Outset product lines, as well as the underlying core business processes
- Leadership and coordination of budget development, staff planning, organizational design, and strategy to anticipate and ensure readiness for future business needs
- Responsible for the forecast and scheduling of all team resources, assignment of projects and team deliverables, overall quality and completion of team deliverables in alignment with organizational launch timelines and regulatory requirements
- Develops and tracks appropriate control methods and key performance indicators (KPIs) to quantitatively measure team success
- Drives professional development and growth of all Product Support Engineers
- Leads strategic direction of the Product Support group
- S. Degree in Biomedical Engineering, Mechanical, Industrial, or Systems Engineering required
- 5-10 years’ experience supporting complex capital equipment (medical devices and/or robotics preferred), including mechanical, electrical, and software elements containing a large number of SKUs
- Experience working in support of a Field Service and/or Technical Support organization, with 5-10 years’ experience in a management role
- Proven record of bringing products to market acting as project/technical leader on behalf of service
- Demonstrated experience influencing product development on behalf of service, familiarity with Design For Serviceability/Maintenance (DFS/DFM) principles and practices
- Experience working in a regulated environment; familiar with Medical Device Regulations – CFR & ISO requirements preferred
- Pragmatic, organized and detailed. Has a big capacity to both think and do, strong on detail and highly organized.
- Ability to promote ideas persuasively, influence others, and build and maintain effective professional relationships with internal partners and business leaders
- An independent thinker willing and able to express and support a point of view.
- Demonstrated ability to think innovatively, connecting the dots when others cannot. Able to make the leap from information to insight.
- Has a quick intelligence, is fast on their feet and quickly responds to issues and questions.
- Great writer and talker. Can organize, summarize, clarify and communicate ideas simply, succinctly, and accurately to engineering and non-technical audiences.
- Capable of maintaining a rapid pace: moves at a nice clip and enjoys having multiple projects going at once. Can change course, be scrappy and get things done on short timeframes.