Biosensor Scientist Jobs (NOW HIRING)

We are a Medtech company developing breakthrough biosensor technologies to transform diagnostics, monitoring, and patient care. With no product on the market yet, this is a rare ground-floor opportunity to join a mission-driven team at the forefront of implantable and wearable sensing innovation. You will play a foundational role in turning cutting-edge sensor science into reliable, regulatory-compliant medical products.

As Chief Engineer, you will provide technical leadership and hands-on ownership of sensor electronics and software development and support. This includes analog/mixed-signal circuit, low-power systems, PCB layout, wireless connectivity (e.g., BLE), embedded firmware, real-time signal processing, algorithms, and software integration for biosensors. You will be part of a tight team, working directly with senior management and the CTO to manage contract efforts provided for the company, and lead the engineering function, collaborate closely with scientific teams, and drive products through design controls, verification/validation, risk management, and manufacturing transfer.

Key Responsibilities

• Provide strategic technical leadership across electronics (analog/mixed-signal circuits, low-power design, PCB layout, wireless connectivity, sensor interfaces) and software (embedded firmware, real-time signal processing, algorithms, data analytics, and supporting application/cloud integration) for our biosensor medical devices.
• Primarily manage and direct external contractors, design partners, engineering service firms, and contract manufacturers responsible for major development activities; set technical direction, review deliverables, ensure quality standards, manage timelines, resolve technical issues, and integrate their output with internal requirements.
• Lead in-house post-delivery device operations, including oversight of sensor refurbishment programs, field performance monitoring, technical support, failure analysis, sustaining engineering, software/firmware updates, and continuous improvement of deployed devices.
• Oversee the full product lifecycle for electronic and software systems—from initial architecture and outsourced development through verification, validation, risk management, manufacturing transfer, commercialization support, and post-market surveillance.
• Build and mentor a lean in-house technical team (including refurbishment technicians and sustaining engineers) while effectively leveraging and coordinating external development resources.
• Ensure full compliance with medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304, IEC 60601, ISO 14971, and cybersecurity requirements across both development and post-market activities. Support regulatory submissions and audits.
• Collaborate cross-functionally with sensor science, mechanical engineering, quality assurance, regulatory affairs, clinical, and manufacturing teams to deliver integrated, reliable biosensor solutions.
• Develop and maintain technical roadmaps, manage supplier and contractor relationships, control budgets and timelines, and contribute to intellectual property development and long-term product strategy.
• Stay current with advancements in biosensor miniaturization, low-power embedded systems, secure connectivity, post-market device management best practices, and evolving medtech regulatory expectations.

Qualifications

• Bachelor’s or advanced degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or related field.
• 10+ years of progressive experience in medical device product development, with a proven track record bringing Class II (or higher) electronics/software‑enabled devices to market.
• Deep expertise in electronics design tools, embedded C/C++, firmware, signal processing, and relevant software languages. Direct biosensor, wearable, or electrochemical/optical sensing experience is strongly preferred.
• Hands‑on leadership building engineering teams and navigating full regulatory pathways (design controls, V&V, risk analysis, submissions).
• Startup mentality: comfortable with high ownership, resourcefulness, and wearing multiple hats.
• Eligible to work in the U.S.; must be based in or willing to relocate to the Charleston, SC area.