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Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

This role is an onsite role. The schedule is Monday - Friday 8 am - 5 pm.

How you'll make an impact:

+ 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 (device master record) spreadsheets

+ Create ESS (Edwards Software Specification) documents for software lifecycle tracking

+ Approve ESS updates

+ Other incidental duties

What you'll need (Required):

+ Bachelor's Degree in an Engineering or Scientific field OR

+ Master's Degree or equivalent in an Engineering or Scientific field

What else we look for (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

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.