Senior Systems Engineer - 9 Month Contract

Cytovale•South San Francisco, CA

11h•Hybrid

About The Position

We are hiring a Senior Systems Engineer who will be an individual contributor within the Engineering group. The Senior Systems Engineer works directly with Project Management and other Engineers (software, hardware, mechanical, electrical engineers and testers) to improve the current design and troubleshoot issues, and work on potential new designs. Additionally, the Systems Engineer works with Marketing, Quality, Service and Manufacturing team members throughout the design process. This role reports to the Systems Engineering manager.

Requirements

Bachelor's Degree in Engineering or a related Science with at least 7 years of medical device Systems Engineering experience, or equivalent industry experience, required.
Experience in electro-mechanical medical devices or diagnostic equipment verification.
Experience in one of the following areas:
Experience developing test plans, requirements, and risk management documents.
Knowledge of regulatory standards such as CFR 820, ISO 14971, ISO 13485, IEC 62304.
A strong desire to work in a small, fast-paced environment of a late-stage startup.
Ability to work in the United States.
This position will be based in the San Francisco Bay area.
Role is 3-4 days per week onsite to carry out role functions.
Some travel may be required (up to 10%).

Nice To Haves

Expertise in design for manufacturing and/or IQ/OQ/PQ.
Expertise in reliability and/or automation desired

Responsibilities

Manage the execution of engineering deliverables associated with the development of IVD products including the support of deliverables for regulatory submissions.
Hands-on design verification: Define verification test approaches (software and hardware) against requirements and translate them into test protocols for Cytovale's in-vitro diagnostic device.
Develop & update requirements at system, instrument and component levels for improved testability and functionality.
Select and apply appropriate statistical approach to verification or validation activities.
Contribute to impact analysis of design changes.
Contribute to process improvements, including risk management and design control.
Contribute to Risk management activities including FMEA and risk analysis (ISO 14971).
Assist with test tools, test method and tool validation.
Assist with troubleshooting and incident investigations.
Perform role function in compliance with Cytovale’s QMS.
Other duties as assigned.