Principal Engineer, Design Quality - Software

Olympus Corporation is a global medical technology company focused on advancing medical technologies and improving patient care. The Principal Engineer, Design Quality - Software role involves providing expertise in software quality and regulatory standards for medical devices, leading development teams, and ensuring compliance with industry regulations.

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
• Provide project management oversight for QMS integration, Quality plans, process updates, and training
• Represent Olympus’s SW development QMS during inspections and audits
• Perform capability audits of software projects
• Establish and monitor performance metrics for SW development activities
• Support the establishment of a response framework for queries and audit findings related to the SDLC
• Communicates significant issues to senior management, including appropriate containment and correction activities, as applicable
• Support post-market surveillance operations including complaint monitoring and metrics. NC, CAPA, HHA, and FCA for software related activities

Requirements:

• Undergraduate (BS) Degree in engineering, computer science, life sciences, or other related degree field
• 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
• 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, 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
• Will work with global teams; availability will include working across the associated time zones; some flexibility in work hours will be expected
• Travel up to 15% of the time
• An Advanced degree such as an MS or PhD is preferred
• Experience in interacting with Regulatory Authorities is preferred
• German and/or Japanese is a plus