Design & Development Lead - Medical Devices

Company Description

Bioscan Research is an ISO 13485:2016 certified medical device company focused on advancing early and objective detection of brain injuries. Specializing in AI-powered, non-invasive neurodiagnostics, the company pioneers cutting-edge photonics sensors to aid in faster clinical decisions and improve outcomes for Traumatic Brain Injury (TBI) patients. Its flagship product, CEREBO, leverages Near-Infrared Spectroscopy (NIRS) to detect deep intracranial hemorrhages within minutes, enabling immediate action in critical situations. Collaborating with clinicians, hospitals, and emergency medical services globally, Bioscan Research combines engineering innovation with clinical expertise to address neurotrauma challenges.

Role Description

We are seeking a highly driven and technically strong Design & Development Lead to head the development of our medical device platforms, including Cerebo. The role requires end-to-end ownership of product development from concept to regulatory-ready design transfer while ensuring compliance with applicable medical device standards (ISO 13485, IEC 60601, IEC 62304, risk management per ISO 14971). The ideal candidate combines deep engineering capability with structured documentation discipline and cross-functional leadership.

Key Responsibilities

-- Product Development Leadership

• Lead end-to-end development of medical devices from concept, feasibility, and prototyping to commercialization.
• Drive EVT, DVT, and PVT builds and ensure design maturity at each stage.
• Define system architecture across electronics, embedded firmware, optics, mechanical, and software layers.
• Ensure alignment of design outputs with product requirements and clinical objectives.

-- System Engineering & Technical Oversight

• Oversee hardware design (analog/digital electronics, PCB design, power systems).
• Guide embedded firmware development (C/C++, RTOS, device drivers).
• Supervise signal processing, algorithm integration, and device-level validation.
• Ensure proper integration of optical systems, sensors, and data acquisition modules.

-- Regulatory & Compliance Integration

• Ensure compliance with:
• ISO 13485 (QMS)
• ISO 14971 (Risk Management)
• IEC 60601 (Electrical Safety & EMC)
• IEC 62304 (Software Lifecycle)
• Contribute to DHF documentation, risk files, design reviews, and validation protocols.
• Support regulatory submissions (CE, CDSCO, US FDA 510(k)).

-- Design for Manufacturing & Scale-up

• Work closely with NPD & Manufacturing/Production teams for design transfer.
• Ensure DFM/DFA compliance and cost optimization.
• Coordinate with contract manufacturers and suppliers.
• Lead technical validation for pilot and production builds.

-- Innovation & Future Product Strategy

• Identify new product opportunities and platform extensions.
• Lead feasibility studies, proof-of-concept development, and IP generation.
• Drive continuous improvement in device performance and reliability.

-- Team Leadership & Cross-Functional Collaboration

• Mentor and manage D&D engineers.
• Conduct structured design reviews and technical decision-making sessions.
• Coordinate with QA/RA, Clinical, and Operations teams.
• Build scalable D&D processes for a growing medtech organization.

Qualifications

• Bachelors or Masters in Electronics, Biomedical, Instrumentation, or related field.
• 612+ years of experience in medical device D&D (preferred).
• Strong understanding of hardware-software integration.
• Experience in regulated environments (medical, automotive, aerospace preferred).
• Experience with prototype development and regulatory documentation.
• Experience in optical systems, NIR, biomedical instrumentation, or diagnostic devices.
• Prior exposure to FDA 510(k) or CE technical documentation.
• Experience working with contract manufacturers and managing NPI builds.
• Familiarity with signal processing and sensor-based systems is highly desirable.