Description:
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