Senior Systems Engineer, Regulated Medical Devices

Organ Recovery Systems Inc.; Itasca (IL); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Annual incentive bonus

Medical, dental, and vision coverage

401(k) with company match

Paid time off

Job summary

Organ Recovery Systems Inc. is seeking a Staff Systems Engineer to strengthen the definition, integration, traceability, verification, and evolution of ORS products and platforms.

You will translate stakeholder needs into system requirements and lead cross-functional workstreams across Jama Connect, Arena, GitHub, and SOLIDWORKS/PDM. You will own risk integration, verification planning, and evidence readiness, collaborating with R&D, Quality, Regulatory, and manufacturing to deliver compliant,

Qualifications

• Bachelor's degree in a relevant engineering field required.
• ABET-accredited degree preferred.
• Master's degree preferred.
• Experience with regulated medical devices and ISO 14971 preferred.
• Eight+ years of systems engineering experience.
• Proven cross-functional leadership and change-management skills.

Responsibilities

• Lead major systems-engineering workstreams across projects and lifecycles.
• Define stakeholder needs, use environment definitions, and system requirements.
• Maintain end-to-end traceability among needs, requirements, architecture, interfaces, risks, and verification.
• Coordinate across R&D, Quality, Regulatory, Operations, Manufacturing, and other functions to ensure an integrated product definition.
• Lead investigations, risk integration, evidence-readiness reviews, and change-impact assessments.

Skills

Systems thinking

Requirements writing

Risk integration

Cross-functional leadership

Change management

Verification & validation

Architecture definition

Education

Bachelor's degree in systems/related field

Master's degree preferred

ABET-accredited preferred

INCOSE/Jama certification preferred

Tools

Jama Connect

Arena

GitHub Enterprise

SOLIDWORKS/PDM

SharePoint

Power BI

Smartsheet

Job description

Organ Recovery Systems Inc. is seeking a Staff Systems Engineer to strengthen the definition, integration, traceability, verification, and evolution of ORS products and platforms.

You will translate stakeholder needs into system requirements and lead cross-functional workstreams across Jama Connect, Arena, GitHub, and SOLIDWORKS/PDM. You will own risk integration, verification planning, and evidence readiness, collaborating with R&D, Quality, Regulatory, and manufacturing to deliver compliant,