Product Systems Engineer – Class II/III Devices

Swoon

Raleigh (NC)

On-site

USD 96,604 - 137,587

Full time

14 days+

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Benefits offered by this job

Medical insurance

Vision insurance

Job summary

A leading healthcare technology company is seeking a Senior Systems Validation Engineer in Raleigh, NC. This role involves providing technical leadership and ensuring compliance with regulatory standards for medical devices. The ideal candidate has over 10 years of experience in software systems engineering and deep knowledge of IEC 62304 and ISO 13485. Responsibilities include mentoring teams, driving software development practices, and leading risk analysis initiatives. Competitive pay rate of $85.00/hr is offered for this 11-month contract position.

Qualifications

10+ years of experience in software systems engineering.
Experience with electro‑mechanical or embedded medical devices.
Knowledge of IEC 62304, ISO 13485, and risk management standards.

Responsibilities

Serve as a technical leader, mentoring engineers.
Drive software systems development best practices.
Translate user needs into system and software requirements.
Lead risk analysis and mitigation for software in regulated devices.
Define verification strategies with full requirements traceability.
Participate in software design reviews.
Support Agile planning and execution.
Partner with teams for effective design transfer.
Ensure compliance with regulatory and quality system requirements.

Skills

Software systems engineering

Regulated industry standards knowledge

Strong communication skills

Documentation skills

Risk analysis

Education

Bachelor’s degree in Engineering or related field

Master’s degree preferred

Job description

This range is provided by Swoon. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$85.00/hr - $85.00/hr

System Validation Engineer

Contract | 11 Months | W2

Shape the Future of Patient Care

We are looking for a highly experienced Senior Systems Validation Engineer to join our Software Engineering organization supporting our Infusion Pump Platforms. In this role, you'll provide technical leadership, drive system-level innovation, and ensure our products meet regulatory standards while improving the lives of millions of patients.

You will be involved in the full product lifecycle—from architecture and development through verification, design transfer, and sustaining engineering—collaborating with cross-functional teams to deliver reliable, life‑saving technology.

Key Responsibilities

Serve as a technical leader, mentoring engineers and guiding architectural decisions
Drive software systems development best practices across product lifecycles
Translate user needs into system and software requirements
Lead risk analysis and mitigation for software in regulated medical devices
Define verification strategies ensuring full requirements traceability
Participate in software design reviews for new features and sustaining projects
Support Agile planning and execution, including backlog and schedule management
Partner with Manufacturing, Service, and Training teams for effective design transfer
Ensure compliance with regulatory and quality system requirements

Required Qualifications

Bachelor’s degree in Engineering or related field (Master’s preferred)
10+ years of experience in software systems engineering
Experience with electro‑mechanical or embedded medical devices
Knowledge of regulated industry standards such as IEC 62304, ISO 13485, and risk management
Strong communication and documentation skills
Proven ability to deliver high‑quality solutions on tight timelines