Remote Lead Software Systems Engineer (Regulated Life Sciences)

Eliassen Group

Cheyenne (WY)

On-site

USD 85,000 - 99,000

Part time

3 days ago

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Benefits offered by this job

Medical, Dental, Vision benefits

401(k) with company matching

Life insurance

Job summary

Eliassen Group seeks a Staff Software Systems Engineer to lead requirements engineering, traceability, and software risk analysis for regulated software-intensive products across mobile, web, and cloud platforms.

The role emphasizes cross-functional collaboration with Product, Regulatory, and Quality teams, driving end-to-end traceability and risk management in Jama Connect or equivalent tools. Remote, W2 contract with comprehensive benefits.

Qualifications

Experience crafting high-quality system and software requirements for software-intensive products.
Track record in end-to-end requirements management and traceability.
Proficiency with regulated environments (medical devices, SaMD) and IEC ISO standards.

Responsibilities

Author, review, baseline, and maintain System and Software Requirements Specifications in Jama Connect.
Decompose system requirements into software requirements with acceptance criteria.
Establish and maintain end-to-end traceability across needs, requirements, design, risk, and verification.
Lead Systems Engineering activities across iOS/Android, web, APIs, cloud services, and backend.
Develop interface requirements, data-flow definitions, workflows, and API specifications.
Partner with Product, Software Engineering, Regulatory, and Quality teams throughout the lifecycle.
Contribute to system hazard analysis and software risk assessment aligned with ISO 14971.
Support verification planning, defect investigations, and release impact assessments.
Drive technical reviews and document decisions; mentor engineers on best practices.