Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Quality Engineer, Software Validation position is a unique career opportunity that could be your next step towards an exciting future.
This is an exciting opportunity for a software quality professional to join a shared service team supporting manufacturing and engineering groups across the Draper facility. The Senior Quality Engineer, Software Validation role will serve as a subject-matter expert and process owner for production and non-product software validation, partnering with cross-functional teams to understand software needs, establishing appropriate validation strategies, and ensure software and associated documentation meet quality, regulatory, and lifecycle requirements.
The role will lead software-validation requests from initial assessment through approval, including developing and reviewing Edwards Software Specifications, supporting validation protocol development and execution, evaluating results and deviations, and approving software lifecycle documentation. This position will also represent the Draper facility on a cross-site council focused on global software-validation standards and process changes.
How You'll Make an Impact:
- Lead and manage software-quality and validation requests from manufacturing, engineering, and other cross-functional teams. Consult with stakeholders to understand software functionality, intended use, risk, validation requirements, and lifecycle documentation needs.
- Serve as a software process owner and approver for production and non-product software validations, ensuring validation strategies, protocols, test results, and reports meet established engineering, quality, and regulatory requirements before implementation or final product release.
- Develop, review, maintain, and approve Edwards Software Specifications (ESS) and other software lifecycle documentation for new or modified manufacturing, inspection, test, and equipment systems.
- Ensure software specifications and validation documentation are appropriately updated when inspection systems, equipment, software applications, or acceptance criteria are created or modified.
- Support cross-functional teams in developing software-validation protocols, executing testing, documenting results, and completing validation reports. Evaluate test results, identify gaps, make recommendations, and determine whether established acceptance criteria have been met.
- Investigate software-quality and compliance issues, including CAPAs, nonconformances, audit observations, software deviations, and validation failures. Lead or support root cause analysis, technical assessments, corrective actions, and investigation reporting.
- Assess software-related risk-management activities and contribute to risk assessments, software hazard analyses, and validation strategies for manufacturing processes, equipment, inspection systems, and test applications.
- Participate in a cross-site software-validation council and represent the Draper facility in the review of global process changes, standards, and validation practices. Partner with stakeholders in Irvine and Ireland to communicate Draper requirements and incorporate site feedback into global decisions.
- Review custom software and acceptance logic used in manufacturing or inspection applications. Create or modify VBA programs, as needed, to support software functionality and acceptance logic.
- Provide technical guidance to engineering teams regarding software lifecycle controls, validation approaches, documentation requirements, deviations, and compliance expectations.
- Other incidental duties as assigned.
What You'll Need (Required):
- Bachelor's degree in an engineering, scientific, computer science, or information systems field with at least 4 years of relevant experience; OR Master's degree in an engineering, scientific, computer science, or information systems field with at least 3 years of relevant experience.
- Experience supporting software quality, software validation, computer system validation, or software lifecycle activities within a regulated manufacturing environment.
- Current or previous experience working in a highly regulated environment
What Else We Look For (Preferred):
- Experience with software quality or computer system validation in the medical device industry.
- Working knowledge of software development lifecycle and validation principles for product and non-product software, manufacturing systems, inspection equipment, laboratory systems, or custom test applications.
- Experience authoring or approving software requirements, software specifications, validation plans, protocols, test scripts, traceability documentation, deviation assessments, and validation reports.
- Experience serving as a software process owner, validation lead, technical approver, or software-quality subject-matter expert.
- Experience leading or supporting CAPAs, nonconformances, software deviations, audit observations, root cause investigations, and technical assessments.
- Experience applying risk-management principles to software, manufacturing equipment, inspection systems, or test applications.
- Programming or scripting experience using VBA.
- Knowledge of LabVIEW, programmable logic controllers, manufacturing execution systems, equipment software, or other manufacturing automation technologies.
- Demonstrated ability to lead cross-functional technical activities, evaluate validation results, investigate software-related issues, and communicate recommendations to engineering and quality stakeholders.
- Experience participating in cross-site or global governance councils, communities of practice, or process-standardization initiatives.
- Strong consulting and stakeholder-management skills, including the ability to translate software requests into validation and documentation requirements.
- Strong technical writing, analytical, problem-solving, organizational, and communication skills.
- Ability to manage multiple requests and priorities in a fast-paced, shared-service environment.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
