Senior Systems Engineer, Medical Devices (Contract)

Select Source International

Plymouth (MN)

On-site

USD 110,000 - 150,000

Full time

31 hours ago

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Job summary

Select Source International in Plymouth, MN seeks a Senior Systems Engineer for a 12-month contract to advance PrisMax ICU therapies. You will drive feasibility through lifecycle management, shaping design concepts, requirements, DHF, risk management, and system integration.

Applicants should have a Bachelor's or Master's in engineering and 3+ years in medical devices, with SysML/UML, DOORS/Jama, and cross-functional collaboration skills to ensure regulatory compliance and robust product

Qualifications

Bachelor’s or Master’s degree in Electrical, Software, Mechanical, Biomedical, or related engineering field with 3+ years in medical devices.
Experience in ICU or kidney care domains is preferred.
Knowledge of SysML/UML and requirements management tools.
Familiarity with design control processes per FDA/ISO guidelines.

Responsibilities

Lead systems engineering across product lifecycle from feasibility to post-market surveillance.
Translate clinical needs into product requirements and design concepts.
Maintain DHF elements and ensure traceability of requirements and risks.
Collaborate with cross-functional teams to mitigate technical risks and meet regulatory standards.
Perform impact assessments on design changes and drive mitigation strategies.