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# Systems Engineer

- **Company:** Finish Line Auto Sales Inc.
- **Location:** Billerica, MA, United States
- **Experience:** Expert
- **Salary:** $129,000.0
- **Contract:** Permanent contract
- **Skills:** Adobe InDesign, Software Engineering, Software Systems, Strategies of Testing
- **Published:** July 7, 2026
- **Apply:** https://www.finishlinestaffing.com/job/sr-systems-engineer/?form=apply#wpjb-scroll

## About the Role

* Bachelor's degree in Mechanical, Electrical, Biomedical, Software Engineering, or a related field (Master's preferred).
 * 7+ years of medical device product development experience in an FDA-regulated environment.
 * Strong expertise in design controls, risk management, and verification & validation.
 * Experience working across mechanical, electrical, and software systems.
 * Excellent leadership, communication, and problem-solving skills., * Startup or early-stage medical device experience.
 * Experience with cardiac monitoring, ECG, electrophysiology, or catheter-based technologies.
 * Knowledge of FDA Design Controls, ISO 14971, IEC 60601, and other applicable medical device standards.

## Description

Join a growing medical device company developing innovative vascular technologies that improve patient care. We are seeking a Senior Systems Engineer to lead product development from concept through commercialization, driving system design, design controls, risk management, and verification & validation (V&V) in a collaborative, cross-functional environment., * Lead system design and product development activities from concept through commercialization.

 * Own design controls, risk management, and system-level V&V.
 * Develop test strategies, protocols, reports, and technical documentation to support regulatory submissions.
 * Provide technical leadership to internal teams and external engineering partners.
 * Collaborate with Engineering, Quality, Regulatory, Manufacturing, and Clinical teams.
 * Drive improvements in product performance, reliability, and manufacturability.


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