Senior Medical Device Software Quality Engineer (Hybrid)

Olympus Corporation; Minneapolis (MN); Hybrid; USD 95,904 - 129,470; Full time

Benefits offered by this job

Annual bonus

401(k) match

Medical coverage

Dental coverage

Vision coverage

EAP

Wellbeing programs

Paid vacation

Parental leave

Holidays

On-site daycare

Cafe & fitness

Job summary

Olympus Corporation in Minnesota is seeking a Senior Design Quality Engineer to lead software quality efforts across the global organization, applying regulatory rigor to Agile SW development and assisting in FDA/PMDA/EU‑MDR submissions.

The role covers software manufacturing, release, and post‑market operations, with anticipated base pay ranging from $95,904 to $129,470 per year, plus potential annual bonus.

Qualifications

• BS degree in engineering, computer science, life sciences, or related field.
• 8 years in software development, software testing, or systems engineering (6 years with advanced degree).
• 5 years in a medical device setting.
• Experience applying standards to medical device software manufacturing, release, and post‑market operations.
• Experience working across national and cultural boundaries.
• Ability to lead and train a large multinational team.
• Strong teamwork and cross‑functional communication.
• Strong English verbal and written communication.
• Availability for global teams; travel up to 15%; work-from-home capability.

Responsibilities

• Advise on software processes including release, manufacturing, and post‑market operations.
• Harmonize software manufacturing and operations across Olympus entities.
• Provide SME on software manufacturing and cloud regulations.
• Provide SME on post‑market monitoring for medical software.
• Update SDLC and operations for manufacture, distribution, and operation monitoring.
• Update SDLC to include product security in software operations.
• Represent Olympus during inspections and audits.
• Perform capability audits of software projects.
• Establish and monitor performance metrics for software operations.
• Support dashboard creation for post‑market software operations.
• Escalate significant issues to senior management with containment plans.

Skills

Software Quality

Agile SW

Regulatory standards

Cross-functional leadership

SDLC

Cloud operations

Post-market operations

Global teams

Time management

English communication

Education

Bachelor's degree in engineering / CS / life sciences

MS or PhD (advanced degree)

Job description

Olympus Corporation in Minnesota is seeking a Senior Design Quality Engineer to lead software quality efforts across the global organization, applying regulatory rigor to Agile SW development and assisting in FDA/PMDA/EU‑MDR submissions.

The role covers software manufacturing, release, and post‑market operations, with anticipated base pay ranging from $95,904 to $129,470 per year, plus potential annual bonus.