Department: R&D / Engineering Department
Reports to: Electrical Engineering Manager
Location: Baldwin, NY
Employment Type: Full-time
Position Objective:
Assist electrical engineering manager in the system design, development, and optimization of electrical medical devices (especially RF devices), ensuring that products meet clinical needs and technical specifications, and support the product lifecycle from concept to mass production. Focus on ensuring that RF medical devices comply with IEC 60601 standards and testing requirements, ensuring regulatory compliance for global sales and applications, while continuously learning and improving electrical engineering and RF systems expertise.
Core Responsibilities:
- System Design and Development:
- Assist in designing the hardware and software components of electrical (RF) systems, including RF generators, electrodes, and other subsystems.
- Prepare system requirement documents under the guidance of senior engineers, and assist in defining initial performance metrics (e.g., power output, temperature control, etc.).
- Support modeling and simulation activities using tools such as MATLAB/Simulink to verify the feasibility of designs.
- Cross-functional Collaboration:
- Work with hardware, software, mechanical engineers, and clinical teams to ensure that the system components work together to meet basic clinical requirements.
- Assist the biomedical team in preliminary analysis of the interactions between RF energy and tissue.
- Testing and Verification:
- Assist in creating and executing system-level test plans, including prototype performance testing, reliability testing, and EMC testing.
- Support testing of medical devices to meet IEC 60601 and other international standards, ensuring the device meets safety, performance, and electrical compatibility requirements.
- Assist in solving technical issues such as RF interference and uneven heat field distribution, and support the analysis and resolution of these issues.
- Regulatory and Risk Management:
- Support ensuring designs comply with global regulatory requirements such as FDA, CE, and NMPA, and assist in drafting relevant technical documentation (e.g., DHF, DMR).
- Assist in executing risk management processes, participate in failure mode analysis, and take appropriate mitigating actions under guidance to ensure compliance with ISO 14971 standards.
- Technical Support and Improvement:
- Support the production team's technical transfer efforts and assist in optimizing the manufacturability of the product (DFM).
- Participate in the continuous improvement of products based on market feedback and project requirements, and assist in developing the next-generation RF ablation technologies.
Qualifications:
- Educational Background:
- Bachelor's degree or higher in Biomedical Engineering, Electrical Engineering, Physics, or a related field.
- Experience and Skills:
- 1-2 years of work experience in medical devices or related industries, with experience in RF ablation, microwave ablation, or electrosurgical devices preferred.
- Understanding of RF circuit principles, signal processing, and basic thermodynamics.
- Familiarity with medical device development processes, risk management (ISO 14971), and medical electrical standards (IEC 60601).
- Familiar with safety standards, electrical compatibility requirements for medical devices, and experience ensuring RF devices comply with these standards and testing requirements.
- Proficient in using basic simulation tools, testing instruments (such as oscilloscopes, spectrum analyzers), and programming languages (Python, C++, LabVIEW, etc.).
- Soft Skills:
- Strong logical analysis and team collaboration skills, with the ability to communicate and collaborate effectively in cross-functional teams.
- Ability to write technical documents in English, with English proficiency as a working language preferred.
- Eager to learn and grow under guidance, improving professional skills.
Development Opportunities:
- With guidance and support, gradually develop into an independent electrical (RF) systems engineer with the ability to design and develop systems, drive personal and project success, and enhance expertise in global medical device compliance.
Job Type: Full-time
Pay: $80,000.00 - $100,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
- Weekends as needed
Ability to Commute:
- In person
- Baldwin, NY 11510 (Required)
Ability to Relocate:
- Baldwin, NY 11510: Relocate before starting work (Required)
As a global company, elliquence educates physicians on the least invasive procedural solutions for spine pathology and provides our unique and specialized tools to support these procedures. The procedures are truly the least invasive solutions available today, and generally begin with targeting the spinal anatomy with a spine needle. Our tag line, “Less is More” is the absolute truth.
What we offer:
Base salary and annual performance-based bonus.
Medical, dental, vision and life insurance
401(k)