Senior Engineer, Software Quality

Imagine how your ideas and expertise can change a patients 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. Youll bring your passion for problem solving and partner with various teams to influence decision-making for a products 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 youll need (Required):
Bachelors Degree in Engineering or Scientific field including either industry or industry/education; 4 years experience required or
Masters 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