Principal Engineer providing expertise in software quality and regulatory standards for Olympus medical technologies. Leading collaboration with development teams to ensure compliance and enhance product delivery.
Responsibilities
Provide professional expertise for Software quality and best practices in SW design, development, release, and support across the global organization
Assist development teams in applying regulatory rigor to Agile SW development practices
Provide subject matter expertise, technical guidance, and leadership for the application of health and medical device SW regulatory standards to the Olympus SDLC
Work with product management, business units, engineering product owners and software architects to define feasible product requirements
Responsible for review and approval of documentation deliverables from assigned projects as required by the SDLC
Requirements
Undergraduate (BS) Degree in engineering, computer science, life sciences, or other related degree field
An Advanced degree such as an MS or PhD is preferred
Minimum of 9 years of experience in the field of software development, software testing, or systems engineering, or minimum of 8 years for advanced degree
Minimum of 6 years of experience in a medical device setting
Experience in the application of relevant standards to medical device software and non-medical device health software development, including Software-as-a-Service
Experience in project management
Experience in interacting with Regulatory Authorities is preferred
Working knowledge in the application of ML/AI to Health SW and medical devices
Experience in working across national and cultural boundaries
Demonstrated capability to lead and train a large and diverse, multinational community with multiple stakeholders
Strong teamwork and communication skills to work effectively on cross-functional project teams
Independent organizational and time management skills is required
Strong verbal and written communication skills in English; German and/or Japanese is a plus
Benefits
Comprehensive medical, dental, vision coverage effective on start date
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