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Electrical Engineer

Strategic Employment Partners (SEP)

About The Role This is a hands‑on electrical design ownership role — not a sustaining or support position. You'll join a small R&D team at a growth‑stage medical device manufacturer developing an FDA‑cleared respiratory therapy system used in hospital settings. The product is a reusable capital device currently in active clinical use, with ongoing development work across PCB architecture, power systems, RF module integration, and embedded hardware interfaces. You'll work directly alongside mechanical, firmware, systems, and regulatory engineers across the full product lifecycle — from schematic through FDA submission. If you want real design ownership, cross‑functional visibility, and the chance to see your work in a clinical environment, this is that role. What You’ll Own Design, maintain, and troubleshoot analog and digital circuits for a hospital‑grade medical device Own PCB development end‑to‑end: schematic design, layout, prototype bring‑up, and testing Power system design, battery management, and hardware interfaces to embedded firmware Integration and validation of wireless/RF modules within a regulated product environment Technical documentation required for FDA submissions, including DHF content Verification and validation activities, including electrical safety and EMI/EMC testing Cross‑functional collaboration with mechanical, firmware, systems, and regulatory engineers — this team moves fast and works closely together Who You Are 3+ years of electrical engineering experience on FDA‑regulated medical devices (capital equipment preferred) Hands‑on experience working under FDA design controls (21 CFR Part 820), including DHF documentation Strong background in analog and digital circuit design PBC design experience using professional EDA tools (Altium, OrCAD, PADs, or similar) Familiarity with IEC 60601 and ISO 13485 environments Bachelor's degree in Electrical Engineering or a closely related field Bonus Points RF / Wi‑Fi (802.11 a/b/g) module design or integration experience EMI/EMC and electrical safety testing exposure Motor control or analog/digital sensor interface design experience Embedded systems or firmware development exposure ISO 14971 risk management experience Background in respiratory, patient monitoring, or other hospital capital equipment Why This Role Work on an FDA‑cleared device actively used in hospital patient care — your work has direct clinical impact Real design ownership on a small R&D team: you'll drive decisions, not just execute tasks Broad technical scope across PCB design, power systems, embedded interfaces, and RF integration — no siloed work Full regulated product lifecycle visibility, from design controls through verification, validation, and FDA submission 10% bonus eligibility, employee flexibility, and meaningful investment in your career development #J-18808-Ljbffr Strategic Employment Partners (SEP)

Vacancy posted 2 days ago
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