Hardware Design Engineer
4 weeks ago
Job Summary:
We are seeking an experienced Hardware Design Engineer Lead to guide the design and development of cutting-edge hardware solutions for medical devices.
You will oversee the full product lifecycle, lead a team of engineers, and ensure compliance with industry standards and regulations.
This role requires technical expertise, leadership skills, and collaboration with cross-functional teams to deliver high-quality, reliable medical devices.
Key Responsibilities
- Lead and mentor a team of hardware and software engineers.
- Set technical goals, review designs, and ensure successful project execution.
- Provide training and foster collaboration within the team.
- Manage the complete lifecycle of Hardware Design development—from concept, design, and prototyping to testing and release.
- Define product requirements with stakeholders and ensure timely delivery.
- Design and develop hardware architectures, including component selection, schematics, and integration with embedded software.
- Conduct hardware bring-up, troubleshooting, and debugging to ensure functionality and reliability.
- Ensure hardware designs comply with medical standards (ISO 13485, IEC 60601, FDA/CE).
- Create and maintain detailed documentation for designs, specifications, and test protocols.
- Support regulatory submissions, audits, and quality management systems.
- Work closely with software engineers to ensure seamless hardware-software integration.
- Partner with quality assurance teams for validation and verification testing.
- Collaborate with manufacturing teams for a smooth transition to production.
- Drive innovation by exploring new components, tools, and techniques to enhance performance and reduce costs.
- Continuously improve design processes and implement best practices.
Experience and Skills Required
- 4–10 years in Hardware Design development, preferably for medical devices.
- Hands-on experience in PCB design, circuit analysis, hardware bring-up, and debugging.
- Knowledge of embedded systems, microcontrollers, sensors, analog/digital electronics, and power management.
- Proficiency in design tools (e.g., Altium Designer, KiCad) and simulation tools (e.g., SPICE, MATLAB).
- Familiarity with medical standards and regulatory processes (ISO 13485, IEC 60601, FDA, CE).
- Strong leadership and mentoring capabilities.
- Excellent communication, problem-solving, and analytical skills.
- Detail-oriented with a focus on quality and compliance.
Preferred Qualifications
- Experience in medical device development and FDA regulatory processes.
- Knowledge of wireless protocols (e.g., Bluetooth, Zigbee, Wi-Fi) for medical applications.
- Proficiency in embedded C/C++ programming for hardware interfacing.
- Expertise in DFM (Design for Manufacturability) and DFT (Design for Testability).
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