Senior Software Quality Engineer

The Senior Software Quality Engineer is responsible for performing design assurance activities for new introductions and sustaining of medical device software. They will work closely with various teams to understand and influence the architecture, requirements, design, testing, and deployment of software designs. The role also involves supporting other design assurance activities, such as data analysis, problem-solving, and continuous improvement of the Quality Management System. The Senior Software Quality Engineer must have knowledge of quality system regulations and experience in developing medical devices in conformance with ISO13485 and 14971 requirements.

Perform design assurance activities for new introductions and sustaining of medical device software

Support the Software Development Lifecycle of one or more projects

Work closely with software design, software testing, project management, product management, regulatory, human factors, and manufacturing teams

Understand and influence the architecture, requirements, detail design, testing, risk evaluation, and deployment of software designs

Support other design assurance activities such as data analysis, problem solving/failure analysis, full QMS compliance, and alignment with software development practices

Ensure 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

Develop and sustain medical devices in conformance with Quality System Regulations, ISO13485, and 14971 requirements

Apply knowledge of IEC 62304 to product development and sustaining engineering projects

Align best practices and techniques for automated unit and integration testing

Monitor customer feedback and report defects found through defect tracking system

Serve as primary quality representative on one or more teams and projects

Lead/contribute to all elements of risk management

Support Design Verification and Validation planning and execution

Develop and execute system-related verification and validation plans and protocols

Identify product quality and quality system improvement opportunities

Support departmental effort in CAPA investigation and completion

Collect, analyze, trend, and communicate quality data throughout the organization

Comply with regulatory requirements, company policies, and operating procedures

Develop and maintain strong relationships with internal and external stakeholders

• Bachelor's degree in Computer Science, Electrical or Software Engineering (or similar) is required. Master's degree preferred.
• 3+ 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.

• Medical
• Dental
• Vision
• EAP/Mental Health
• Life Insurance/AD&D
• Short/Long Term Disability
• FSA (Dependent & Healthcare)
• HSA w/ Employer contribution
• Commuter Benefits
• 401K w/ company match
• ESPP
• Fertility benefits
• Wellness initiatives
• Legal Assistance
• Pet insurance
• Financial Advisement & Wellbeing
• Tuition Reimbursement
• Student Loan Payback
• Employee discounts
• Professional Development/Learning
• Collaboration Days (lunch onsite)
• Happy Hours/Karaoke
• PTO/Sick time
• Holidays + Volunteer Day