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# Senior Systems Engineer

- **Company:** Experis
- **Location:** Plymouth, MN, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Systems Engineering, Failure Mode Effects Analysis, Iq/oq/pq, System-level Testing
- **Published:** May 19, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=ad30861eac49f10a

## About the Role

Our client, a leader in the medical device industry, is seeking a Senior Systems Engineer to join their team. As a Senior Systems Engineer, you will be part of the Engineering Department supporting product development, validation, and regulatory compliance. The ideal candidate will demonstrate strong analytical skills, attention to detail, and a proactive approach to problem-solving, which will align successfully in the organization., * Extensive experience with design validation, process validation, and equipment validation in a regulated environment.

 * Strong knowledge of regulatory standards including FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
 * Proficiency in risk management tools such as DFMEA, PFMEA, and hazard analysis.
 * Experience with system-level testing, verification protocols, and validation documentation.
 * Excellent collaboration skills to work effectively across cross-functional teams and external partners.

## Description

* Review and approve engineering drawings, process validation protocols, SOPs, control plans, and reports to ensure compliance with industry standards.
 * Lead process control and monitoring of Critical to Quality (CTQ) parameters, implementing methodologies such as Six Sigma and Lean Manufacturing for continuous improvement.
 * Support validation projects for existing products, new processes, and equipment, ensuring adherence to FDA, GMP, ISO 13485, and ISO 14971 standards.
 * Collaborate on risk management activities, including remediation of Process FMEA (PFMEA), updating Design FMEAs, and conducting hazard analyses to meet global regulatory requirements.
 * Develop and execute system-level test strategies, supervise CAPA activities, and document evidence for regulatory submissions such as FDA and CE technical files.


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