OB SUMMARY: The Hardware Engineer is responsible for the development, maintenance, and support of high complexity technology solutions in both a new product development and current model environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
? Develop and maintain hardware solution for medical devices
? Designs and coordinates research and test to validate, analyze and solve technical problems.
? Applies technical competencies and knowledge to solve problems of a routine nature, or improve upon exiting designs or processes.
? Analyze requirements, develop specifications, perform technical design review, risk and reliability analysis
? Considers cost and efficiency when making decisions.
? Has a broad understanding of other functional areas.
? Documents status and results accurately and succinctly, and with purpose.
? Seeks input from more experienced individuals to improve quality of deliverables
? Other duties may be assigned.
EDUCATION AND EXPERIENCE:
? Bachelor degree or above
? 5 years of engineering experience in product design and development.
? Excellent background in fundamentals of circuit design and analysis.
? Familiar with industry leading software tools for schematic entry and PCB layout design. Altium designeris prefered.
? Hands-on experience with analog/digital circuit and em
? Hands-on experience with em
? Hands-on experience with selection electrical components (including cable, Fuse, and Filter etc.)
? UL/IEC 60601-1 experience is preferred. Working knowledge of ISO13485 and CE/UL certification is a plus.
? Experience in design QA, DFx, and DFMEA are preferred.
? Experience in designing circuits involving more than One of the following is preferred.
? Battery, Power supply, Transformer and Motor control.
? Previous experience with Medical Devices, FDA, CFDA Regulations or other applicable regulatory requirements.
QUALIFICATIONS AND SKILLS:
? Strong Interpersonal skills with the ability to work collaboratively with others in a team environment.
? Good understanding of product design and development life cycle.
? Excellent root cause analysis and problem solving skills.
? Strong ability to multi-task and adapt in a dynamic work environment.
? Low level analog, sensor interfacing (magnetic, optical, current etc.), wireless technologies.
? Familiarity with EMC/EMI/ESD standards and compliance is necessary for success in this role.
? Strong organization and communication skills
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