Senior Medical Devices Systems Engineer (Hybrid)

Select Source International; Plymouth (MN); Hybride; USD 110 000 - 140 000; Plein temps

Résumé du poste

Select Source International in Plymouth, MN is seeking a Senior Systems Engineer to drive systems engineering across the product lifecycle, from feasibility to post-market. You will capture requirements from clinical needs, regulatory standards, and stakeholders, and guide design realization with a systems perspective.

The role requires 3+ years in medical devices or regulated fields, strong SysML/UML and requirements practice, and collaboration across global teams to deliver compliant, robust

Qualifications

• Bachelor's or Master's degree in engineering or science.
• 3+ years of relevant experience in medical devices or regulated industries.
• Experience with system modeling languages and requirements management tools.
• Familiar with DOORS, Teamcenter, TrackWise8, JIRA, and ALM.

Responsabilités

• Lead systems engineering across the product lifecycle.
• Translate clinical and user needs into product requirements.
• Manage requirements, traceability, and DHF maintenance.
• Drive risk management and design verification activities.
• Coordinate with cross-functional teams and stakeholders.
• Ensure compliance with FDA, ISO and IEC design controls.
• Use various software tools to support responsibilities.

Connaissances

SysML/UML

Requirements management

Medical devices

Cross-functional collaboration

Risk management

Software/hardware integration

Formation

Bachelor's or Master's degree in engineering or science

Outils

DOORS

Teamcenter

TrackWise8

JIRA

ALM

Description du poste

Select Source International in Plymouth, MN is seeking a Senior Systems Engineer to drive systems engineering across the product lifecycle, from feasibility to post-market. You will capture requirements from clinical needs, regulatory standards, and stakeholders, and guide design realization with a systems perspective.

The role requires 3+ years in medical devices or regulated fields, strong SysML/UML and requirements practice, and collaboration across global teams to deliver compliant, robust