Olympus is looking to improve software quality and best practices in SW design, development, release, and support across its global organization, and assist development teams in applying regulatory rigor to Agile SW development practices. This role will provide subject matter expertise, technical guidance, and leadership for the application of health and medical device SW regulatory standards to the Olympus SDLC.
Requirements
- Experience in the application of relevant standards to medical device software and non-medical device health software development, including Software-as-a-Service.
- Working knowledge in the application of ML/AI to Health SW and medical devices.
- Experience in project management.
- Experience in the field of software development, software testing, or systems engineering.
- Experience in a medical device setting.
- Experience in interacting with Regulatory Authorities is preferred.
Responsibilities
- Advise SW development teams on Software development processes and practices (SiMD/SaMD/Health SW/Cloud).
- Advise SW development teams on architecture in the context of regulatory impact, safety, security and best practices.
- Investigate and implement harmonization of SW processes across different Olympus legal entities.
- Advise Olympus as a Subject Matter expert on regulations around health software development, and software for medical devices.
- Collaborate on the update of SDLC and operations processes and activities for the inclusion of ML/AI development, cloud infrastructure, and validation best practices.
- Collaborate on the update of SDLC and operations processes and activities for the inclusion of security-by-design and privacy-by-design in SW development.
- Collaborate with development teams on applying Agile development practices for continuous rapid product delivery while maintaining compliance and quality.
Other
- Undergraduate (BS) Degree in engineering, computer science, life sciences, or other related degree field.
- Demonstrated capability to lead and train a large and diverse, multinational community with multiple stakeholders, working in a collaborative, coaching, mentoring and/or influencing capacity.
- Strong teamwork and communication skills to work effectively on cross-functional project teams, Interacting with a diversity of disciplines such as R&D, Quality Engineering, Regulatory Affairs, etc.
- Independent organizational and time management skills is required.
- Strong verbal and written communication skills in English; German and/or Japanese is a plus.
