**This role will require full-time, on-site presence in Philadelphia for the initial 1-2 months. Following this period, the position will transition to a hybrid on-site/remote arrangement, with the possibility of becoming fully remote thereafter.**
Company Overview:
We are a cutting-edge technology company specializing in wearable medical devices. Our mission is to enhance patient care through innovative sensor technologies and advanced data analytics, focusing on health monitoring solutions that address critical needs in healthcare. We are dedicated to pushing the boundaries of medical device development and improving outcomes through real-time, data-driven insights. We are looking for a talented Senior/Executive level Electrical Engineering Consultant.
Key Responsibilities:
- Design and Development : Lead the design and development of electrical systems for wearable devices, ensuring high performance and reliability in sensor technology.
- Clinical Trials : Collaborate with clinical teams to implement and supervise trials, ensuring compliance with regulatory standards and optimal device functionality in real-world settings.
- System Integration (IOT) : Oversee the integration of hardware and software components, ensuring seamless functionality and user experience.
- Supervision of Contractors : Manage and supervise third-party contractors and engineering teams to ensure project goals and timelines are met effectively.
- Regulatory Compliance : Navigate FDA clearance processes, including 510(k) submissions, and ensure that all product development adheres to relevant medical standards (ISO 13485, IEC 60601).
- Strategic Leadership : Provide technical guidance and leadership, potentially stepping into a CTO role as the company grows, and contribute to strategic decision-making.
- Collaboration : Work closely with the CEO and other stakeholders to align engineering efforts with business objectives.
Qualifications:
- Education : Bachelor’s or Master’s degree or PhD in Electrical Engineering.
- Experience : Minimum 5+ years of experience in medical device development, particularly with wearable technologies. Clinical trial experience beneficial.
- Technical Skills : Proficiency in circuit design, embedded systems, and signal processing specific to physiological monitoring. WebApp experience beneficial.
- Regulatory Knowledge : Strong understanding of FDA regulations and experience with medical device clearances.
- Leadership Abilities : Demonstrated experience in leading teams or projects, with strong supervisory skills for overseeing contractors and internal engineers.
- Problem-Solving : Excellent analytical and problem-solving skills, with the ability to innovate under pressure.
- Communication Skills : Strong verbal and written communication skills, capable of effectively presenting technical information to non-technical stakeholders.