• Create & release engineering drawing/design specs, and BOM updates for parts/sub-assemblies and packaging

• Conduct/run test of products

• Run production/line sustaining projects

• Creating/revising MVP, IQ, OQ, PQ, & FMEA documents for both internal and contract manufacturers (CMs) as well as review validation for process validation and capability

• Drafting both DV protocol and DV reports

• Lead in qualifying manufacturing tools & equipment updates with secondary suppliers

• Execute tests for implantable leads for both electrical (DC resistance and Hipot) and mechanical

(flex testing, material durability/strength using an instron machine) properties

• Responsible for the Implantable side of Business – IPG, Impulse Generator (Class 3) device,

Lead devices (Class 3) and Accessories (Class 2 and 3)

• Execute tests for implantable leads for both electrical (DC resistance and Hipot) and mechanical

(flex testing, material durability/strength using an instron machine) properties

• Create & release engineering drawing/design specs, and BOM updates for parts/sub-assemblies and packaging

• Conduct/run test of products

• Make sure production lines are continuously working

• Quality Engineering support that involved document control which included organizing COC/FAI document packages as well as DMR and CAPA documents.

• Work with manufacturing/assembly teams in updating a list of all tools and their recent calibration dates as well as updating work instructions/manufacturing processes instructions and BOM lists

• Assist inspectors with inspecting and verifying that parts are made to required design specifications for both dimensions and cosmetic requirements

• Manage quality issues/concerns for customers and within the company as well as with suppliers

• Coordinate/conduct customer and ISO 13485:2016 (Medical Devices) audits

• Design/create plans for solar panel placement based on given measurements or research measurements

of a roof as well as follow fire and construction codes

• Make sure panels face in a certain orientation to obtain optimal electric power and was aesthetically pleasing