Position Overview:

The Senior Software Quality Engineer is responsible for performing design assurance activities for new introductions and sustaining of medical device software, with the purpose of supporting the Software 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, software testing, project management, product management, regulatory, human factors, and manufacturing teams to understand and influence the architecture, requirements, detail design, testing, safety and cybersecurity risk evaluation and deployment of the software designs to the market.

This person must be versatile to support other design assurance activities such as data analysis, problem solving/ failure analysis, full QMS compliance and alignment with the software development practices, Business Process Optimization initiatives and continuous improvement to the Quality Management System. Additionally, this person must be able to perform as a Quality Assurance representative for hardware and disposable-related projects to support system-level reliability improvements when needed. They also help guide and mentor other team members in a collaborative environment.

Essential Job Functions and Responsibilities 

• Work closely with Regulatory, R&D, Test and Manufacturing, to ensure the adoption and use of best practices, Quality tools, and Design Control methodologies
• Support Software Quality Assurance (SQA) strategy and operational execution plans
• Knowledge of and experience in developing and medical devices in conformance with Quality System Regulations, ISO13485, ISO14971, ISO62304 and SW96 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 for software, hardware, disposables, and system changes.
• Lead / Contribute to all elements of safety and cybersecurity risk management. Assesses risk by facilitating the development of risk management tools 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 for medical and non-medical device software.
• 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 for proper escalation and applicable resolution.
• 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
• Support internal and external audits
• Support additional activities, as assigned

Required Qualifications 

• Bachelor’s degree in Computer or Engineering Science, Electrical or Software Engineering (or similar) is required. Master’s degree preferred.

• Minimum of 5 years of hands-on experience in the Quality Engineering discipline.

• Prior experience in the medical device field is required; preferably experience with Capital Equipment medical 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.
• Thorough knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 14971 (Risk Management) requirements, ANSI/ AAMI SW96, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
• Strong written and verbal communication skills.
• Must be able to communicate fluently in both written and spoken English

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 departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers.

• Certified Quality Engineer a plus.
• Lead Auditor certification a plus.
• Lean Certification a plus.
• Experience with statistical analysis software a plus.