Senior Engineer, Design Quality, Software

About the role

The Senior Design Quality Engineer provides professional expertise for Software quality and best practices in SW development across the global organization and assists development teams in applying regulatory rigor to Agile SW development practices, including SW release and manufacturing.

Responsibilities

• Advise SW development and operations teams on Software processes and practices including SW release, manufacturing, and post-market operations.
• Working with global cross functional teams, explore and implement harmonization of SW manufacturing and operations processes across different Olympus legal entities.
• Advise Olympus as a Subject Matter expert on regulations around SW manufacturing and cloud operations.
• Advise Olympus as a Subject Matter expert on regulations around SW post market monitoring for Medical and Health Software products.
• Collaborate on the update of SDLC and operations processes and activities for the manufacture, distribution, and operations monitoring of SW.
• Collaborate on the update of SDLC and operations processes and activities for the inclusion of product security in SW operations environments.
• Represent Olympus’s SW manufacturing and post-market operations QMS during inspections and audits.
• Perform capability audits of software projects.
• Establish and monitor performance metrics for SW manufacturing and post-market activities.
• Support the establishment of a dashboard for post market operations for SW products.
• Communicates significant issues to senior management, including appropriate containment and correction activities, as applicable.

Requirements

• Undergraduate (BS) Degree in engineering, computer science, life sciences, or other related degree field.
• Minimum of 8 years of experience in the field of software development, software testing, or systems engineering, or 6 years for advanced degree.
• Minimum of 5 years of experience in a medical device setting.
• Experience in the application of relevant standards to medical device software manufacturing, release, and post-market operations.
• 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.
• Candidate will be able to work from home on a regular basis.

Qualifications

• An Advanced degree such as an MS or PhD is preferred.
• Experience in interacting with Regulatory Authorities is preferred.
• Japanese communication skill are an optional, added plus factor.