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.
How you will make an impact:
• Support non-product software validation related activities for manufacturing and test/inspection equipment. This includes authoring, reviewing, and approving software validation deliverables such as software validation plan, requirements definition document, test protocols, and validation reports
• Support Software Risk Management activities including authoring of Software Hazard Analysis for complex projects / systems / test equipment in partnership with cross-functional teams
• Train, coach, and guide other employees on software validation requirements and best practices
• Collaborate with stakeholders on the Code Review process for custom manufacturing test equipment
• Other Incidental duties
What you'll need (Required):
• Bachelor's Degree in Engineering or Scientific field including either industry or industry/education; 4 years experience required or
• Master's Degree or equivalent in Engineering or Scientific field including either industry or industry/education; 3 years experience preferred or
• Ph.D. or equivalent preferred
• Previous experience working with Software VNV (Verifications and Validation) preferred
• Other: Related certification preferred (e.g., CSQA) preferred
What else we look for (Preferred):
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Working knowledge and understanding of statistical techniques
• Previous experience with Risk Management required
• Substantial 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.
• Substantial knowledge of business acumen products and software technologies
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• 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
.png)
