Principal Software Design Quality Engineer

South Bay, CA

Posted: 09/17/2018 Employment Type: Direct Hire Industry: Healthcare Job Number: JOS000007882

Full-time

Company Overview Outset is a pioneering medical technology company that puts the patient before the machine. Our human-centered model is designed to dramatically improve not only the care experience – for patients, families, providers and physicians alike – but also cost-efficiency of dialysis delivery. We believe in introducing technology innovation in order to drive service model innovation. And in doing so, we intend to profoundly and permanently impact what, where and who can dialyze.

Position Overview

The Software Quality Engineer is responsible for performing a wide range of Quality Engineering activities, with the purpose of supporting the R&D, Test and Manufacturing departments. The incumbent for this position will support the development of one or more projects from concept generation through production, having the unique opportunity to realize the entire product lifecycle. With a specific focus on software, this person will work closely with software and electrical design teams, manufacturing, and suppliers to understand and influence the architecture, requirements, detail design, testing, and deployment of the SW designs.

Essential Job Functions

• Work closely with Regulatory, R&D, Test and Manufacturing, to ensure the highest quality products and processes are being developed and deployed.
• Create Software Quality Assurance (SQA) strategy and operational execution plans.
• Offer technical expertise 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 and IEC 60601 to product development and sustaining engineering projects.
• Engage with the developer community to align best practices and techniques for automated unit and integration testing.
• 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.
• 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 write test reports.
• Identify product quality and quality system improvement opportunities and drive procedure updates when required.
• Supports new product launches to ensure suppliers are capable of delivering to the required quality standards
• 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 to ensure optimal performance
• Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance Excellent interpersonal skills
• A self-starter, motivated and able to positively motivate others
• Focused, target driven with a positive, can-do attitude

Requirements/Qualifications -
Bachelor’s degree in Computer Science, Electrical or Software Engineering (or similar). Master’s degree preferred. -
Minimum of 10 years of hands on experience with Design Assurance / Quality Engineering. -
Prior experiences in the medical device field is required, preferably experience with Capital Equipment medical devices. -
Previous experience supporting external audits (example: Notified Body or FDA) -
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. -
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
 

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