Staff, Design Quality Engineer

Company Overview

Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost, because patients deserve “better” now, not some day.  

At Outset we’re revolutionizing an industry and changing lives. We’re impacting what the future of dialysis looks like by creating a first-of-its-kind technology in order to reduce the cost and complexity of dialysis. FDA cleared for use across care settings, from the hospital to the clinic to the home, the Tablo® Hemodialysis System harnesses modern technology for a new holistic approach to dialysis care. We’re giving providers time back to focus on patient care. And we’re giving patients the power to take control of their life and get back to enjoying the things they love.

Position Overview 

As a key member of the Quality Team, the incumbent will support quality activities related to the design, development, and reliability.  The Staff Quality Engineer ensures that compliance to customer, risk management, quality, and Design Control requirements is demonstrated and helps to ensure successful transfer of the design to manufacturing.  They are responsible for accurate and independent generation and evaluation of Design History File documentation and overall Quality System compliance. They also help guide and mentor other team members in a collaborative environment.

Essential Job Functions and Responsibilities 

• Provide technical and statistical support to Product Development, Manufacturing and Quality organizations.
• Assist with major efforts, or phases of projects, to resolve advanced and complex technical and Quality-related problems.
• Contribute to New Product Introduction Projects as a core team member and communicate activities to the extended team members of Quality.
• Support the product development teams in the adoption and use of best practices, Quality tools, and Design Control methodologies.
• Leads root cause investigation using Lean Principles and Tools.
• Perform Risk Analysis including Fault Tree Analysis (FTA), Human Factors/Usability, and Failure Mode and Effects Analysis (FMEA) activities to ensure risks are identified and appropriately addressed.
• Support Risk Management activities to ensure design and process shortcomings are identified and appropriately addressed.
• Monitor and develop reliability improvements to existing & new designs.
• Support Post Market Surveillance in the investigation of product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence.
• Support verifications/validations either at Outset or with external vendors for cost, quality, and capacity initiatives.
• Report on achievement of targets and identify any actions required.
• Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP’s, QSR 21 CFR Part 820 and ISO 13485.
• Evaluate quality data and prepare regular reports to monitor trends.
• Generate, review and approve Engineering and Development Change Orders for Design Assurance
• Excellent interpersonal skills.
• A self-starter, motivated and able to positively motivate others.
• Focused, target driven with a positive, can-do attitude.
• Excellent problem-solving skills.
• Excels in a fast-paced environment.

Required Qualifications 

• Bachelor’s degree in Engineering or Science (or similar) is required. Master’s degree is preferred.
• Minimum of 7 years of hands-on experience in the Quality Engineering discipline.
• Prior experiences in the medical device field is required; preferably experience with Capital Equipment medical devices.
• Thorough knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.

Desired Qualifications  

• A self-starter, motivated and able to positively motivate others.
• Focused, target driven with a positive, can-do attitude.
• Drive to assigned objectives which delivers best practice results, added value and continuous improvements across the business and quality management system.
• Leadership and interpersonal skills to develop and manage good working relationships with internal depa