Senior Systems Requirements Engineer — Remote (SaMD)

Eliassen Group; Helena (MT); On-site; USD 177,655,000 - 206,309,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with match

Life insurance

Job summary

Eliassen Group is seeking a Staff Software Systems Engineer to lead requirements engineering and end-to-end traceability across mobile, web, backend, APIs, SDKs, and cloud services. You will coordinate with Product, Architecture, Verification, Regulatory, and Quality teams in a regulated life sciences setting.

You will drive risk analysis, hazard evaluation, and interface specifications while ensuring alignment across multiple stakeholders and ensuring compliant software development practices.

Qualifications

• 8+ years in Systems Engineering or requirements engineering for software-intensive products.
• Experience with Jama Connect or equivalent for traceability (DOORS, Polarion, CodeBeamer).
• Experience with iOS, Android, web apps and APIs.
• Regulated environments such as medical devices, digital health, SaMD.
• Familiarity with IEC 62304 and ISO 14971.

Responsibilities

• Author and maintain System and Software Requirements Specifications in Jama Connect with strong decomposition, allocation and change control.
• Decompose system requirements into software requirements and define acceptance criteria with Product and Engineering.
• Establish end-to-end traceability across needs, requirements, design, risk controls, and verification evidence.

Skills

Systems Engineering

Requirements management

Traceability

Regulated environments

Education

Bachelor's degree in Systems Engineering

Master's degree preferred

Tools

Jama Connect

DOORS

Polarion

CodeBeamer

Jira

Confluence

GitHub

Job description

Eliassen Group is seeking a Staff Software Systems Engineer to lead requirements engineering and end-to-end traceability across mobile, web, backend, APIs, SDKs, and cloud services. You will coordinate with Product, Architecture, Verification, Regulatory, and Quality teams in a regulated life sciences setting.

You will drive risk analysis, hazard evaluation, and interface specifications while ensuring alignment across multiple stakeholders and ensuring compliant software development practices.