MedTech Product Owner — Systems & Software Lead

Stark Pharma Solutions Inc; Minneapolis (MN); On-site; USD 110,000 - 165,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a Senior Product Owner with 10+ years of software or systems engineering experience, preferably in medical devices or regulated environments, to oversee product requirements, software development, and cross-functional leadership in Minnesota.

The role emphasizes translating roadmaps into technical requirements, managing traceability, and ensuring compliance with IEC 62304 and FDA guidance while supporting hardware-software integration and lifecycle

Qualifications

• 10+ years of software or systems engineering experience.
• Experience translating requirements into architectures and software designs.
• Experience working in Agile development environments.

Responsibilities

• Lead product and feature definition with cross-functional teams.
• Translate roadmaps into requirements, user stories, and acceptance criteria.
• Manage system and subsystem requirements, decomposition, analysis, and traceability.
• Support software and hardware integration activities.
• Identify and resolve technical risks and complex system issues.
• Collaborate with engineering on root cause analysis and solutions.
• Review software designs against requirements and expected behavior.
• Support software lifecycle from concept through testing and release.
• Ensure compliance with quality and medical device development requirements.
• Mentor and guide team members on requirements, testing, traceability, and releases.

Skills

Software engineering

Systems engineering

Cross-functional leadership

Education

Bachelor's degree in Engineering or CS

Tools

C++

Job description

Stark Pharma Solutions Inc. is seeking a Senior Product Owner with 10+ years of software or systems engineering experience, preferably in medical devices or regulated environments, to oversee product requirements, software development, and cross-functional leadership in Minnesota.

The role emphasizes translating roadmaps into technical requirements, managing traceability, and ensuring compliance with IEC 62304 and FDA guidance while supporting hardware-software integration and lifecycle