Senior Software Design Assurance Engineer

Role Overview

• Provides technical and quality system guides related to establishing software requirements.
• Provide quality oversight for software verification and validation activities for new products in accordance with design planning procedures.
• This includes, but is not limited to, reviewing and approving software test case protocols and reports, reviewing software development plans, and reviewing other system and software documentation.
• Leads meetings to prioritize, review, and/or approve action plans for addressing issues captured in problem resolution systems during development.
• Leads risk evaluation and associated management activities related to software development, including Risk assessments (e.g., FMEA), product risk analysis, and mitigation of software issues.
• Participates in technical and management reviews to ensure design plans, product design, and deliverables related to product software are met.
• Represent the quality engineering function for the review and approval of designated design outputs.
• Provide quality oversight for non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports, and other documentation as required.
• May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team.
• Complies with US FDA regulations, other country regulatory requirements, company policies, and procedures.
• Maintains a strong, collaborative partnership with cross-functional team members, especially with R&D.
• Works as an individual contributor and may provide guidance or oversee the work of other QE team members.
• Develop and conduct training of company personnel for the divisional software development and validation program.
• Support audits and lead quality system improvement activities.

Requirements

• Bachelor’s degree in engineering or a technical field
• Minimum of 5 years related work experience in Quality or a related field.
• Knowledge of regulations, standards, and guidance affecting medical software and non-medical device software development.
• Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.
• Advanced degree (preferred)
• Previous quality engineering experience and demonstrated use of quality tools/methodologies (preferred).
• Experience working in a broader enterprise/cross-division business unit model (preferred).

Tech Stack

• Cyber Security

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit
• an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.