The person will essentially be reviewing failures from the testing lab and determining if there's design flaws and if so, working with the team over in China to correct the designs.
Responsibilities
Help the Sustaining teams with IEC 60601-1 (Product Safety) and IEC 60601-1-2 (EMC) testing, protocol development, and report writing
Read and make minor updates to schematics, layouts, BOM’s, and other design outputs as needed utilizing Altium Designer
Assist with updating Electrical lab equipment qualifications, test methods, test method validations, protocols, and reports
Researches, develops, designs, and tests electrical components, equipment, software systems, and networks.
Provide clear communication to stakeholders as necessary
Leverage internal/external partners as necessary to achieve project objectives
Work cooperatively with Cross Functional teams- Process Development, Quality, Manufacturing, Regulatory, Clinical, and Marketing, to ensure project success
Provide work direction to Technicians, Interns, and Suppliers as necessary
Investigate, research, and select components, tools, equipment, and best practices
In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance with all documented quality processes and procedures
Qualifications
Bachelor’s Degree in Electrical Engineering, Computer Engineering, Mechanical Engineering, or similar with 4-5years of experience
Previous experience with IEC 60601-1 and IEC 60601-1-2
Must be a self-starter and willing to reach out to cross-functional team members to facilitate design changes
Preferred Qualifications
Excellent organizational, communication, and collaboration skills
Solid medical device design control process and documentation experience (i.e., Windchill)
Experience with electro-mechanical systems and accessories
CAD drawing or Electrical schematic, BOM management, and manufacturing/supplier transfer experience is a major plus
Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Engineering and Information Technology
Industries
Appliances, Electrical, and Electronics Manufacturing and Medical Equipment Manufacturing
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