Principal Electrical Engineer (R&D)

Job Description

As a technical leader, responsible for leading the development of robust electrical engineering designs and working as part of a multifunctional group to develop electromechanical medical devices. Engage in the full product lifecycle, from inception to final product. Work collaboratively with customers and marketing and operations partners to perform customer research, design, test, and document electrical components, architectures, systems, and products. Job duties:

• Work in cross functional teams to identify the customer needs and develop system to meet these needs.
• Own the development of electrical/hardware design for electromechanical products.
• Ideate and conceptualize unique design solutions for unmet product needs.
• Develop theory of operation, system specifications, test plans, protocols, and reports for designs.
• Debug analog, power, and communications related issues of systems.
• Evaluate different components to determine optimum solution for the application.
• Design and test functional safety and optimal shielding/grounding for compliance.
• Ensure product design meets requirements of standards and regulations (e.g., Basic Electrical Safety, EMC, etc.).
• Work with regulatory stakeholders to identify all compliance requirements for medical devices with electronics.
• May be required to guide, mentor, and supervise assemblers, technicians, and engineers.
• Develop and maintain vendor relationships.
• Responsible for specifying, acquiring, and maintaining electrical laboratory equipment.
• Interface with appropriate internal and external resources to generate intellectual property and ensure intellectual property is appropriately protected.
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
• Perform additional duties as assigned.

Qualifications

1. Bachelor’s degree in electrical engineering.
2. Minimum of ten (10) to twelve (12) years of related work experience, including minimum six (6) years of medical device industry experience.
3. Strong written and verbal communication skills.
4. Experience designing electronic systems compliant to IEC60601.
5. Experience designing and testing electronics in safety-critical applications.
6. Experience in designing and testing mains powered electronics.
7. Strong debugging and root cause analysis skills with new, unique problems as they pertain to testing designs, product use, and manufacturing processes.
8. Experience with schematic capture and layout of PCB assemblies using ECAD software (e.g., Altium Designer, Allegro, Xpedition, Pads, etc.).
9. Ability to analyze electrical systems using simulation software (e.g., LTspice, PSpice, etc.) to improve design and performance.
10. Proficient in operating Oscilloscopes, Spectrum Analyzers, DMMs, power supplies, etc.
11. Proficient with MS Word, Excel, Outlook, and Teams.

Desired Qualifications

1. Master’s degree in electrical engineering.
2. Understanding of AC/DC motor operating principles and technical challenges.
3. Experience in analog, low noise, and high precision electronic design.
4. Experience with Altium Designer.
5. Working knowledge of medical devices and FDA regulations.
6. Experience with CAPA systems, including complaint handling.
7. Ability to receive the appropriate inoculations required to enter an operating room environment.
8. Experience programming microcontrollers using C or C++.