Engineer I, Software Quality

About the position

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.

Responsibilities

• 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

Requirements

• Bachelor's Degree in an Engineering or Scientific field OR
• Master's Degree or equivalent in an Engineering or Scientific field

Nice-to-haves

• 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