Senior Product Owner – R&D Engineer

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

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Senior Product Owner R&D Engineer

Location: Minnesota

Duration: Long Term

Job Overview

We are seeking a Senior Product Owner with 10+ years of experience in software or systems engineering, preferably within medical devices or other regulated industries. The role focuses on product requirements, software development, systems engineering, and cross-functional leadership.

Key Responsibilities

• Lead product and feature definition activities with cross-functional teams.
• Translate product 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 teams on root cause analysis and solutions.
• Review software designs against requirements and expected behavior.
• Support software lifecycle activities 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.

Required Qualifications

• Bachelor's Degree in Engineering, Computer Science, or related discipline.
• 10+ years of software engineering or systems engineering experience.
• Strong experience with C++.

Experience Creating And Managing Software/system Requirements.

• Experience translating requirements into architectures and software designs.
• Experience working in Agile development environments.

Experience With Medical Devices Or Other Regulated Industries Preferred.

• Knowledge of IEC 62304 and Class II/Class III medical device standards.
• Knowledge of FDA Cybersecurity Guidance and GDPR.
• Strong technical leadership, communication, and problem‑solving skills.
• Experience with complex hardware, embedded firmware, and software systems is a plus.
• Master's Degree in Engineering or Computer Science is preferred.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.