Responsible for providing R&D and quality engineering support to ensure the successful development of MiniMed devices, design transfers, scale-up and ongoing operational support. Work with Design and Quality control on product design, verification and validation testing, test method development, and manufacturing transfer support for Class II and Class III medical devices. Perform prototyping/fixture creation and design documentation. Navigate complex regulations and standards including FDA Quality Systems Regulations (QSR) 21 CFR 820, ISO 13485, ISO 10993-1, and American Society for Testing and Materials (ASTM) D4169. Responsible for pre and post Market risk analysis activities including Fault Tree Analysis, Process and Design Failure Mode Analysis (PFMEA and DFMEA), and Corrective and Preventative Actions (CAPA). Analyze post-market surveillance data, investigate and respond to complaints. Coordinate Design of Experiments (DOE) based on knowledge in Sampling Techniques and Statistical Analysis. Responsible for the development of Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) and Gage R&R. Utilize Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) in association with technical report creation and Engineering Change Order (ECO) routing. Leverage 2D Drafting and 3D Modeling using CADs software for design of robust and manufacturable device components including plastic injection molding, utilizing SolidWorks and Geometric Dimensioning and Tolerancing (GD&T) application. Position works a hybrid model and will be onsite at the San Diego, CA location 4 days per week. Salary: $105,000 - $125,000. Job Requirements: Requires a Master's degree in Mechanical, Industrial, Chemical or Biomedical Engineering or related engineering field plus two (2) years of experience in R&D Engineer or related occupation for medical devices. Must possess at least two (2) years' experience with each of the following: • Product design, verification and validation testing, test method development, and manufacturing transfer support for Class II and Class III medical devices; • Prototyping/fixture creation and design documentation • FDA QSR 21 CFR 820, ISO 13485, ISO 10993-1, and ASTM D4169. • Risk analysis activities including Fault Tree Analysis, PFMEA, DFMEA, and CAPA • Analyzing post-market surveillance, investigating and responding to complaints • DOE, Sampling Techniques, and statistical analysis • IQ/OQ/PQ and Gage R&R • ECOs, technical reports, and compliance with GMP and GDP. • 2D Drafting and 3D Modeling using CADs software for design of robust and manufacturable device components including plastic injection molding, utilizing SolidWorks, GD&T application. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation MiniMed offers a competitive salary and flexible benefits package. Salary range for U.S. (excl. PR) locations (USD): $105,000.00 to $125,000.00 Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).