Co-op – Software Design Assurance

Jobtailor; California (MO); On-site; USD 25,000 - 36,000; Full time

Job summary

Jobtailor is seeking a student with strong analytical skills to support medical device software programs in Plymouth, MN. You will help ensure lifecycle compliance, perform documentation reviews, and support risk management across cross-functional teams including Regulatory Affairs and Quality.

You'll gain hands-on experience with design reviews, cybersecurity documentation, and Software Bill of Materials while advancing with AI-powered tooling and dashboards in a collaborative office setting.

Qualifications

• Pursuing a Bachelor's or Master's degree in a technical field such as Software Engineering, CS, or related engineering disciplines.

Responsibilities

• Support software-intensive medical device programs through software lifecycle compliance, documentation reviews, requirements traceability, quality metrics, and audit-readiness activities.
• Collaborate with Software Design Assurance, Software Development, Systems Engineering, Regulatory Affairs, Product Security, and Quality teams.
• Assist with design/review prep, risk management documentation, verification evidence, cybersecurity and Software Bill of Materials records.
• Support digitalization and continuous improvement efforts including process mapping, dashboards, knowledge management, and AI-based workflow adoption.
• Build knowledge of medical device design controls, software lifecycle processes, risk management, and quality systems.

Skills

Analytical Thinking

Attention to Detail

Organization

Written Communication

Verbal Communication

Education

Bachelor’s or Master’s in Software Engineering/CS/engineering field

Tools

Python

Power BI

SharePoint

Git

Azure DevOps

Codebeamer

Job description

• Support software-intensive medical device programs through software lifecycle compliance, documentation reviews, requirements traceability, quality metrics, and audit-readiness activities
• Collaborate with Software Design Assurance, Software Development, Systems Engineering, Regulatory Affairs, Product Security, and Quality partners
• Assist with design and technical review preparation, risk management documentation, verification evidence, cybersecurity and Software Bill of Materials documentation, and compliance records
• Support digitalization and continuous-improvement work, including process mapping, dashboards, knowledge management, and adoption of AI-based software lifecycle tools and workflows
• Build practical knowledge of medical device design controls, software lifecycle processes, risk management, cybersecurity, and quality systems

Requirements

• Currently pursuing a Bachelor’s or Master’s degree in Software Engineering, Computer Science, Biomedical Engineering, Computer Engineering, Systems Engineering, Electrical Engineering, or a related technical field
• Strong analytical thinking, attention to detail, organization, and written and verbal communication
• Familiarity with software development, testing, Agile methods, requirements management, data analysis, or cybersecurity is a plus
• Experience through university projects, coursework, laboratories, prior internships, or co-ops is welcome
• Exposure to Python, Power BI, SharePoint, Git, Azure DevOps, Codebeamer, or similar tools is a bonus
• Must successfully perform minimum Physical, Cognitive and Environmental job requirements with or without accommodation
• Must have US work authorization; sponsorship is not available now or in the future
• Must reside in or within commuting distance to Plymouth, Minnesota
• Must be able to work in an office environment

Core Competencies

Demonstrates strong analytical thinking and attention to detail while supporting software lifecycle compliance and documentation for medical device programs. Familiarity with software development processes, risk management, and cybersecurity is essential.

Highest-signal resume keywords

• Software Lifecycle Compliance
• Risk Management Documentation
• Cybersecurity
• Agile Methods
• Data Analysis

Hard Skills

• Software Development
• Requirements Management
• Quality Metrics
• Verification Evidence
• Process Mapping

Soft Skills

• Analytical Thinking
• Attention to Detail
• Organization
• Written Communication
• Verbal Communication

Industry Keywords

• Medical Device Design Controls
• Software Bill of Materials
• Continuous Improvement
• Digitalization
• Knowledge Management

Tools & Technologies

• Python
• Power BI
• SharePoint
• Git
• Azure DevOps