Senior Software Design Quality Engineer (Hybrid)

Olympus America, Inc.; Brooklyn Park (MN); Hybrid; USD 96,000 - 129,000; Full time

Job summary

Olympus America, Inc. is seeking a Senior Engineer, Design Quality, Software to lead software quality practices across the SDLC, support regulatory submissions, and ensure compliance with ISO 13485, 21 CFR 820, and IEC 62304.

This role partners with global development teams and post-market operations. You will advise on software processes for release, manufacturing, and post-market monitoring, establish metrics, and help implement product security and SDLC updates.

Qualifications

• Undergraduate (BS) Degree in engineering, computer science, life sciences, or other related degree field.
• Minimum of 8 years of experience in 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 applying relevant standards to medical device software manufacturing, release, and post-market operations.
• Experience working across national and cultural boundaries.
• Strong teamwork and communication skills to work effectively on cross-functional project teams.
• Will travel up to 15% of the time; some flexibility in work hours with global teams.

Responsibilities

• Advise SW development and operations teams on Software processes and practices including SW release, manufacturing, and post-market operations.
• Work with global cross functional teams to harmonize SW manufacturing and operations processes across Olympus entities.
• Advise as Subject Matter Expert on regulations around SW manufacturing, cloud operations, and post-market monitoring for Medical and Health Software products.
• Collaborate on updating SDLC and operations processes for manufacture, distribution, and monitoring of SW; include product security considerations.
• Represent Olympus’s SW manufacturing and post-market operations QMS during inspections and audits.
• Perform capability audits of software projects and establish performance metrics for SW manufacturing and post-market activities.

Skills

Software development

Software testing

Systems engineering

Teamwork

Communication

Leadership

Education

BS in engineering / related field

Job description

Olympus America, Inc. is seeking a Senior Engineer, Design Quality, Software to lead software quality practices across the SDLC, support regulatory submissions, and ensure compliance with ISO 13485, 21 CFR 820, and IEC 62304.

This role partners with global development teams and post-market operations. You will advise on software processes for release, manufacturing, and post-market monitoring, establish metrics, and help implement product security and SDLC updates.