Careers that Change Lives A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people.Join us as we engineer the extraordinary! Engineers create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide. We reward you in the ways that matter most to you. We offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare. Learn more about Medtronic benefits and compensation at the bottom of this job description. Medtronic Neuromodulation and Pelvic Health, in Fridley, Minnesota, is currently looking for a Senior Electrical Engineer - Released Product Engineering .This will be a hybrid position with the expectation of being onsite at our Rice Creek, Minnesota facility three days a week. A Day in the Life In this role, you will be responsible for device electrical hardware design leadership for market-released implantable medical devices. You will work collaboratively with cross-functional partners such as reliability, regulatory, operations, and sourcing to evaluate and implement design changes.You will also represent the organization as the prime technical contact on contracts and projects. Responsibilities will include but are not limited to: 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 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 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 New Product Development 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; ensuring completion of all transfer deliverables Must Haves - Minimum Requirements Bachelor’s degree in a technical discipline required Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience Nice to Have Degree in Electrical or Biomedical Engineering Electrical design experience in a regulated medical industry Experience using statistical and data analysis tools. SPC, DOE, Gauge R&R, CpK Working knowledge of Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive, and ISO (13485:2003) Experience using 6 Sigma (DFSS) principles