Biomedical Search
Description
Position Overview
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.
Key Responsibilities
- 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.
Qualifications
- 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.
Preferred Qualifications
- 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.