Electrical Engineer

• Lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
• Responsible for technical and mechanical design leadership for market-released implantable cardiac devices.
• Collaborate with cross-functional partners such as reliability, regulatory, operations, and sourcing colleagues to evaluate and implement design changes.
• Represent the organization as the prime technical contact on contracts and projects.
• Interact with personnel on significant technical matters often requiring coordination between organizations.
• Identify and oversee testing required to obtain necessary data to support field actions, regulatory renewals, submissions and deficiency responses.
• Provide critical evaluation of device design when representing design in review of Change Impact Forms (CIF’s).
• Initiate change activity (CA) to modify and maintain design documentation (BOM’s, Specs, drawings).
• Support CAPA’s (Corrective & Preventive Actions) and RPI’s (Released Product Investigations) including possible CAPA ownership.
• Provide RPE input to new product development teams.
• Assist Regulatory Specialists by providing design & clinical use data and rationale to support worldwide regulatory submissions and certification renewals.
• Support IQ/OQ/PQ, DOE’s, SPC, Gauge R&R, Sampling methodologies, Data Analysis, Hypothesis Testing, Modeling/Predictive Analyses, Capability Studies (CpK) and Component Qualifications.
• Collaborate with reliability and manufacturing personnel to determine and execute appropriate tests/assessments to evaluate supplier, process, material, design, or component changes prior to implementation.
• Collaborate with reliability, manufacturing, materials, and R&D to investigate product performance issues/returned product analysis to identify root cause(s) and implement corrective action(s).
• Assist manufacturing sites with lean layout initiatives, interfacility transfers and outsourcing.
• Support cost reduction and continuous improvement projects.
• Provide problem solving/trouble shooting support to manufacturing sites and key suppliers to increase yields, maintain process capability, and improve efficiency and cost.
• Support internal and external regulatory compliance audits.
• Actively participate in new product development to RPE transfers; ensure completion of all transfer deliverables.

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