Job Purpose
Receives minimal technical direction/review on a broad scope of new complex R&D/manufacturing and test equipment projects. Independently, or as member of a team; develops concepts, and executes specifications, designs, plans and builds of multiple complex internal manufacturing and test equipment projects.
Viewed as an expert in one or more technologies.
• Managing an IEC 60601-1 testing project, serving as main point of contact with test laboratory, triaging issues to core team members, troubleshooting test issues, documenting of test plan, test report
• Performing standards-based testing, specifically EMC and safety testing
• Supporting different divisions for sustaining fielded products
• Analyzing design changes from individual circuits up to fully configured products
• Component analysis for BOM replacements, specifying needed testing to support a BOM replacement
• Testing new or replacement circuit board level components, assessing results against test criteria
• Assessing electrical and system compatibility between medical devices
• Working with internal manufacturing or contract manufacturing on manufacturing associated challenges
• Analyzing challenges or failures of circuit boards, cables, power supplies, or displays
• Electrical testing of PCBAs and products, documenting and implementing design updates
• Working cross-functionally with quality, regulatory, sourcing, and manufacturing departments
• Support regulatory submissions by answering questions about test results, rationale for design requirements, or standards compliance
• Ensure compliance with internal Quality System requirements across all engineering documentation
Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Minimum Qualifications
• Bachelor’s degree or higher in systems or electrical engineering from an accredited institution.
• Minimum of 7 years' experience in electrical engineering, particularly in electrical hardware design and test execution
• Experienced with test equipment such as multimeters, oscilloscopes, signal generators, spectrum analyzers, network analyzers, as well as manual tools such as soldering irons and crimpers.
Preferred qualifications:
• Background in a regulated industry, preferably with Class II or III medical devices.
• Strong familiarity and experience with IEC 60601-1 and IEC 60601-1-2, background in testing
• Strong verbal and written communication skills with the ability to clearly convey technical concepts.
• Ability to manage tasks independently while collaborating across multidisciplinary teams
• Ability to work cross-functionally across engineering, quality, regulatory, and manufacturing.
• Experience with Altium PCB layout tool
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