Senior Medical Device Systems Engineer – Lifecycle Expert

VIVA USA Inc

Plymouth (MN)

On-site

USD 90,000 - 130,000

Part time

4 days ago

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Job summary

VIVA USA Inc is seeking a System Engineer (contract) to guide the technical direction of Acute Therapies products. You will drive product development from feasibility through lifecycle management, shaping design concepts, requirements, and risk strategies.

Responsibilities include systems integration, design history file maintenance, and ensuring FDA/ISO/IEC design controls are followed. A strong background in electro-mechanical and software engineering is required, with cross-functional

Qualifications

Bachelor’s or Master’s degree with 3+ years of relevant experience in engineering or science.
Experience with medical devices preferred, ICU/kidney care domains a plus.
Strong systems engineering knowledge including electro-mechanical and software aspects.

Responsibilities

Conduct systems engineering activities across product lifecycle, from development to post-market surveillance.
Translate clinical/user needs into product requirements and design concepts.
Capture requirements from sources like regulatory standards, human factors, quality, and manufacturing.
Manage design history files and support risk management, verification, and validation.