Sr. Design Quality Engineer

Position Description:

Sr. Design Quality Engineer for Medtronic, Inc located in Northridge, CA. Coordinate and provide process design quality support for the new product development programs by applying methodologies such as Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), and Design for Manufacturing Assembly (DFMA) during process design and development phase. Drive risk management deliverables by facilitating and generating process failure modes effects analysis (PFMEA) and Hazard Analysis and facilitate and execute process FMEAs. Develop Process Parameters (P-diagram), Input-Process-Output (IPO) matrices, process characterizations, test methods and process validation strategies (IQs/OQs/PQs) and Test Method Validations (TMVs) for new products in development. Use statistical techniques or data analysis including hypothesis testing, confidence and tolerance intervals, regression, capability analysis, Design of Experiments (DOEs), Gauge R&R (GR&R), to inform design decision making and conclusions for deliverables like test method validations, process characterizations and verification, process validation and reliability demonstration activities. Navigate various government and industry standards for the development and use of medical devices including FDA QSR (Quality Systems Regulations), ISO13485, ISO14971, and EU Medical Device Regulations (EU MDR). Utilize Good Manufacturing Practices (GMP). Coordinate Design Control, Design Verification and Process Validation. Coordinate Root cause investigations and Corrective and Preventive Actions (CAPA).

Basic Qualifications:

Master’s degree in Mechanical Engineering, Biomedical Engineering or related engineering field and two (2) years of experience as a manufacturing or quality engineer or related occupation for medical devices. Must possess at least two (2) years of experience with each of the following: DRM, DFSS, and DFMA, PFMEA, Hazard Analysis, and FMEAs; Developing Process Parameters, Process Development, DOE, test methods, IQ/OQ/PQ, and TMV for new product development; Performing data analysis to include hypothesis testing, confidence and tolerance intervals, regression, capability analysis, and GR&R; FDA QSR, ISO13485, ISO14971, and EU MDR; GMP; Design Control, Design Verification and Process Validation, Root cause investigations, and CAPA.

Salary: $94,400 to $141,600 per year