Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring. The Engineer I, Software Quality role focuses on ensuring the quality and compliance of software products through documentation, investigation of issues, and collaboration with team members throughout the product lifecycle.
Develop basic software documentation for product or non-product software validation deliverables utilizing engineering knowledge
Investigate basic product / non-product software quality and compliance issues (e.g, CAPA, non-conformances, audit observations, software deviations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports
Assess Risk Management activities for basic projects / systems / test equipment in collaboration with team members
Collaborate with team members on the Code Review process for basic product software or manufacturing test equipment
Drive validation of COTs (commercial off-the-shelf) and modified COTs systems in manufacturing/testing environments
Create programs in VBA (visual basic for applications) language for acceptance logic
Create and validate DMR (discrepant material report) spreadsheets
Create ESS documents for software lifecycle tracking
Approve ESS updates
Other incidental duties
Qualification
Required
Bachelor's Degree in an Engineering or Scientific field OR
Master's Degree or equivalent in an Engineering or Scientific field
Preferred
Internship experience, medical device industry preferred
Previous experience working with Software VNV (Verifications and Validation)
Knowledge of programming languages (ex: LabView, PLC, and/or VBA)
Good computer skills in usage of MS Office Suite; CAD experience preferred
Basic documentation, communication and interpersonal relationship skills
Basic understanding of statistical techniques
Good understanding and knowledge of principles, theories, and concepts relevant to Software Development Lifecycle related to Software Quality Engineering (e.g., CQE body of knowledge) for product and non-product software.
Good problem-solving, organizational, analytical and critical thinking skills
Good understanding of processes and equipment used in assigned work
Knowledge of and adherence to related procedures (e.g., Cybersecurity procedures related to IT systems, manufacturing equipment or product software).
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Benefits
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
