Staff Quality Engineer Product Quality

About the role

The Staff Quality Engineer, Product Software Development will provide quality leadership on new product project teams responsible for the development of medical device software systems. The role will also serve as the subject matter expert in requirements gathering, facilitating software risk assessments, defining test strategies, and guiding project teams on design controls and defect analysis.

Responsibilities

• Support the design, development and testing of Medical Device Software, including Software as a Medical Device (SaMD) products.
• Provide leadership, guidance and expertise on the software development process, procedures and practices.
• Enhance processes to better reflect state of the art practices and drive continuous improvement.
• Partner with R&D to refine requirements, and to ensure that architecture/design documents are comprehensive.
• Facilitate the documentation and tracking of verification activities, including code review findings.
• Review test case execution results and manage defects.
• Facilitate software risk assessment sessions and own the development of risk documents.
• Support regulatory filings and registrations.
• Support internal and external audits or inspections of SaMD products and processes and own Non-conformances or CAPAs and drive root cause investigations.
• Support audits of software suppliers and software consultants.
• Conduct training on Medical Device Software development processes and quality systems.
• Train and mentor new engineers and lower-level quality engineers.
• Provide expertise in applicable industry standards and regulations including, but not limited to as IEC 62304, FDA guidance, FDA Part 11, ISO13485, EU MDR, ISO14971, IEC 62366, ISO 27001, and HIPAA.
• Provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures, as well as medical device regulations.
• Ensure that patient’s ePHI and PII data is protected and security requirements are met.

Qualifications

• Agility
• Analytical Reasoning
• Coaching
• Collaboration
• Critical Thinking
• Model-Based Systems Engineering (MBSE)
• Product Design
• Report Writing
• Requirements Analysis
• Research and Development
• SAP Product Lifecycle Management
• Scripting Languages
• Software Architectures
• Software Development Management
• Software Engineering Practices
• Software Quality Assurance (SQA)
• Systems Development Lifecycle (SDLC)
• Technologically Savvy

Pay

The anticipated base pay range for this position is: $109,000.00 - $174,800.00

Benefits

• Time Off Benefits: Vacation - 120 hours per calendar year, Sick time - 40 hours per calendar year, Holiday pay, including Floating Holidays - 13 days per calendar year, Work, Personal and Family Time - up to 40 hours per calendar year, Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child, Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year, Caregiver Leave - 80 hours in a 52-week rolling period, Military Spouse Time-Off - 80 hours per calendar year.
• Additional Benefits: Consolidated Retirement Plan (pension), Savings Plan (401(k)), Long-term Incentive Program.