We are seeking a skilled Electrical Engineer with hands-on experience in R&D of electro-mechanical medical devices. The ideal candidate will have expertise in mixed-signal analog/digital circuit design, EMC and product safety compliance, and cross-functional product development.
Key Responsibilities:
• Lead and support R&D activities across full product lifecycle – from feasibility and prototyping to system-level design.
• Design and analyze mixed-signal circuits for medical device applications.
• Develop EMC and Product Safety strategies and documentation for new and existing products in alignment with applicable standards (IEC/EN 61326-1/2-6, UL/IEC 61010, 60950/62368-1).
• Author and execute EMC test plans and reports; conduct troubleshooting and root cause analysis.
• Interface with external certifying bodies (UL, CE, CB Scheme) to ensure product compliance.
• Support validation activities, including protocol/report generation and execution (V&V, CAPA).
• Provide technical guidance on design changes related to EMC/Safety impacts.
• Maintain and operate EMC/Safety testing equipment; write equipment SOPs.
• Collaborate closely with electrical, mechanical, and quality engineering teams.
Qualifications:
Required:
• Bachelor’s degree in Electrical Engineering or related field (or equivalent combination of education and technical experience).
• 5–8 years’ experience in circuit design, product safety, and EMC testing in a regulated environment.
• Proficiency in tools such as ORCAD Capture, PSpice, and Mentor Graphics PADS.
• Strong understanding of EMC/Safety standards, FDA-regulated product environments, and IVD device compliance.
Preferred:
• Bachelor's in Electrical, Biomedical Engineering, or Physics.
• Experience interfacing with certification agencies.
• Familiarity with UL file maintenance, CE Technical Files, and FDA quality systems.
Skills & Attributes:
• Strong problem-solving and documentation skills.
• High level of integrity, collaboration, and adaptability.
• Excellent verbal/written communication and attention to detail.
• Ability to lead and contribute within cross-functional teams.