Minimum Qualifications:
- 5+ years of experience in electrical engineering, with significant focus on medical devices or biomedical sensing systems.
- Demonstrated ability to independently lead and deliver complex medical device hardware development projects from concept through design verification and validation.
- Deep hands-on expertise with design and integration of electrical components of miniaturized medical device systems such as PCBs, PCB components, batteries, and light-emitting and detecting systems.
- Expertise in mixed-signal circuit design for physiological sensing, including signal generators, amplifiers, filters, ADCs, and low-noise data acquisition systems.
- Experience designing low-power architectures and battery management systems for body-worn medical devices.
- Experience with EMC/EMI design practices and electrical safety standards (IEC 60601-1, IEC 60601-1-2).
- Experience leading formal design reviews and presenting technical analyses to cross-functional stakeholders in a design-controlled environment.
- Proficiency in PCB design tools (Altium Designer preferred), including rigid, flex, and rigid-flex designs for space-constrained wearable form factors.
- Strong technical writing skills, with experience authoring design documentation for regulated environments.
- Experience managing PCB fabricator and contract manufacturer relationships, including vendor qualification and supply chain risk mitigation.
- B.S. in Electrical or Biomedical Engineering or a related field.
Preferred Qualifications:
- Knowledge of biosensing and electrical stimulation technologies and proficiency in hardware implementations of these technologies.
- Experience with optoelectronic circuit design, including LED drivers, photodiode front-ends, and transimpedance amplifiers (TIAs).
- Experience with mechanical-electrical integration for miniaturized wearable enclosures and collaboration with mechanical engineering teams.
- Familiarity with C/C++ and embedded systems integration with BLE-enabled microcontrollers (e.g., Nordic nRF series) for wireless physiological data streaming.
- Experience directing and reviewing work from external PCB layout and design contractors.
- Experience designing medical wearable hardware for manufacturability (DFM) and testability (DFT), including development of test fixtures and validation systems.
- Experience with design verification and validation (V&V) testing in a regulated medical device environment.
- Experience supporting FDA regulatory submissions (e.g., 510(k), de novo) and familiarity with design controls under 21 CFR Part 820 or ISO 13485.
- Experience with hardware FMEA and risk management per ISO 14971.
Job Responsibilities:
- Design low-power architectures, battery charging circuits, and power budgets for portable and wearable device platforms.
- Design for safety and electromagnetic compatibility (EMC/EMI), conduct pre-compliance testing, and support formal EMC and electrical safety testing per IEC 60601-1 and IEC 60601-1-2.
- Drive and lead design reviews with multi-disciplinary stakeholders, establishing rigorous engineering practices and collaborating closely with firmware, mechanical, and software engineers to ensure seamless system integration.
- Independently manage relationships with PCB fabricators and assemblers; oversee BOM cost, sourcing risk, and component lifecycle to supply finished, high-quality electronics.
- Lead test fixture design and manufacturing test strategy, from prototype PCB evaluation through design transfer and production yield optimization.
- Author and review technical reports, maintain schematic libraries and design history files (DHF), and contribute hardware FMEA and risk management files (ISO 14971) to support regulatory submissions (510(k), de novo).
- Report to the Electrical Engineering R&D Manager.
