Senior Software Engineer with full - stack experience developing scalable web applications for EHSQ management software at Intelex.
OA
Hybrid Principal Engineer, Design Quality - Software
Posted last week
About the role
- 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
- 24/7 Employee Assistance Program
- Free live and on-demand Wellbeing Programs
- Generous Paid Vacation and Sick Time
- Paid Parental Leave and Adoption Assistance
- 12 Paid Holidays
- On-Site Child Daycare, Café, Fitness Center
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