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 Senior Software Quality Engineer is responsible for performing design
assurance activities for new introductions and sustaining of medical device
software aligned with the product management team, with the purpose of
supporting the R&D, Test and Manufacturing departments. The incumbent for this
position will support the Software Development Lifecycle of one or more
projects from concept generation through production. This person will work
closely with software design, electrical design, and manufacturing teams to
understand and influence the architecture, requirements, detail design,
testing, risk evaluation and deployment of the software designs.
This person must be versatile to support other design assurance activities
such as data analysis, problem solving/ failure analysis, QMS compliance,
Business Process Optimization initiatives and continuous improvement to the
Quality Management System.
Essential Job Functions and Responsibilities
- Work closely with Regulatory, R&D, Test and Manufacturing, to ensure the proper design controls are being developed and deployed.
- Create Software Quality Assurance (SQA) strategy and operational execution plans.
- Offer design assurance guidance in the testing area within the organization
- Knowledge of and experience in developing and medical devices in conformance with Quality System Regulations, ISO13485 and 14971 requirements.
- Applies knowledge of IEC 62304 to product development and sustaining engineering projects.
- Engage with the development team to align best practices and techniques for automated unit and integration testing.
- Continuously monitor customer feedback and report defects found through defect tracking system, provide necessary information to reproduce the defect to arrive at a solution.
- Serve as primary quality representative on one or more teams and projects.
- Lead / Contribute to all elements of risk management. Assesses software risk by facilitating the development of risk management tools such as Fault tree analysis, failure mode and effects analysis (FMEAs) and contribute to the completion of the overall product risk management file.
- Support Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities. Develop and execute system related verification and validation plans and protocols, and test reports.
- Identify product quality and quality system improvement opportunities and drive procedure updates when required.
- Support departmental effort in CAPA investigation and completion.
- Collect, analyze, trend, and communicate quality data throughout the organization.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Develop and maintain strong relationships with internal and external stakeholders
- Excellent interpersonal skills
- A self-starter, motivated and able to positively motivate others
- Focused, target driven with a positive, can-do attitude
- Bachelor’s degree in Computer Science, Electrical or Software Engineering (or similar) or equivalent experience
- Minimum of 8+ years of hands-on experience with Design Assurance / Quality Engineering.
- Prior experiences in a regulated medical device environment.
- Experience working with capital devices with embedded software and/or digital health initiatives is required.
- Ability to work effectively in a fast paced and dynamic environment.
- Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers.
- Strong written and verbal communication skills.
You are part of an organization that attracts and hires the best talent on the
planet! You will be working with a great team of dedicated, friendly and
knowledgeable individuals, developing novel and game changing product(s). We
are dedicated to the development and growth of our Teammates.
In return, we offer you an opportunity to become a highly influential teammate
who can build and support a first class Quality Engineering function by
providing intelligence, discipline, problem solving and collaborative skills
that can improve designs and processes.