Software Quality Engineer - Salt Lake City, United States - BRIOHEALTH SOLUTIONS INC

Description

Job Description

Software Quality Engineer

BrioHealth Solutions Inc., Inc. is seeking a Software Quality Engineer to support design quality efforts for an active implantable medical device, covering both clinical and commercial needs in a GMP environment. In this role, you will be involved in every stage of in the software development lifecycle, from requirements definition to post-market surveillance.

Responsibilities

· Collaborate with cross-functional teams including engineering, development, and regulatory affairs to ensure compliance with all relevant standards and regulations (e.g., FDA, ISO

· Analyze test results, identify root causes of defects, and document corrective actions.

· Participate in risk assessments and develop risk mitigation strategies for software.

· Maintain a deep understanding of relevant medical device quality system regulations (QSRs, etc.) and standards (IEC 62304, etc.).

· Manage, lead the creation and maintenance of sFMEAs

· Prepare and/or review, approve, and maintain quality system documentation, including test plans, test cases, reports, and software related NCs/CAPAs.

· As applicable manage the control, verification and validation of SOUP that is used in medical devices.

· Stay up to date on the latest advancements in medical device software requirements.

· Participate in software team meetings as needed, e.g., Scrum, etc.

· Measure the effectiveness and efficiency of software processes (e.g., Functional Verification Tests (FVT), cost, yield, customer impact, defect detection, defect containment, Total Defect Containment Effectiveness (TDCE), Defect Removal Efficiency (DRE), and process capability).

· Review and approve software test strategies, plans, designs, etc.

Requirements

· Minimum 5+ years of experience as a Software Quality Engineer in the medical device industry, with a strong focus on Class III active implantable devices.

· Proven experience in developing and executing comprehensive test plans for medical device software.

· In-depth knowledge of software development methodologies (e.g., Agile, Waterfall, incremental, DevOps, etc.)

· Understand software configuration items such as, baselines, documentation, software code, and equipment) and identification methods (e.g., naming conventions and versioning schemes).

· Understand requirements development (e.g., Product, data/information, security, quality, etc.) and associated management methods.

· Use software verification and validation methods (e.g., static analysis, structural analysis, mathematical proof, simulation, and automation) and provide input regarding which tasks should be iterated because of modifications.

· Strong understanding of risk management principles applied to medical device software.

· Excellent analytical and problem-solving skills.

· Superior written and verbal communication skills.

· Ability to work independently and as part of a cross-functional team.

· Familiarity with relevant medical device standards (e.g., IEC 62304, IEC 60601, ISO and guidance documents such as General Principles of Software Validation: Guidance for Industry and FDA Staff (Final Guidance).

· Certified Quality Engineer (CQE) or Certified Software Quality Engineer (CSQE) is a plus.

· Experience with implantable medical devices.

· Knowledge of FDA IDE regulations.

· Familiarity with FDA complaint handling procedures during an IDA and post PMA.

· Experience with Six Sigma or other quality improvement methodologies.

BrioHealth Solutions Inc., Inc. is an advanced medical device company dedicated to the research, development, and commercialization of a miniaturized implantable ventricular assist system (CH-VAD) featuring total magnetic suspension (TMS) for the treatment of end-stage chronic heart failure. With offices in the U.S. and China, we are growing our U.S. team in preparation for clinical studies and regulatory approval in the U.S. and Europe