Sr. R&D Engineer

MiniMed•San Diego, CA

3d•$105,000 - $125,000•Hybrid

About The Position

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.

Requirements

Master’s degree in Mechanical, Industrial, Chemical or Biomedical Engineering or related engineering field.
Two (2) years of experience in R&D Engineer or related occupation for medical devices.
At least two (2) years’ experience with Product design, verification and validation testing, test method development, and manufacturing transfer support for Class II and Class III medical devices.
At least two (2) years’ experience with Prototyping/fixture creation and design documentation.
At least two (2) years’ experience with FDA QSR 21 CFR 820, ISO 13485, ISO 10993-1, and ASTM D4169.
At least two (2) years’ experience with Risk analysis activities including Fault Tree Analysis, PFMEA, DFMEA, and CAPA.
At least two (2) years’ experience with Analyzing post-market surveillance, investigating and responding to complaints.
At least two (2) years’ experience with DOE, Sampling Techniques, and statistical analysis.
At least two (2) years’ experience with IQ/OQ/PQ and Gage R&R.
At least two (2) years’ experience with ECOs, technical reports, and compliance with GMP and GDP.
At least two (2) years’ experience with 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.

Responsibilities

Provide R&D and quality engineering support for device development, design transfers, scale-up, and ongoing operational support.
Collaborate 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 ASTM D4169.
Conduct pre and post-market risk analysis activities including Fault Tree Analysis, PFMEA, DFMEA, and 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.
Develop Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), and Gage R&R.
Utilize GMP and GDP in association with technical report creation and ECO routing.
Leverage 2D Drafting and 3D Modeling using CADs software (SolidWorks) for design of robust and manufacturable device components, including plastic injection molding, utilizing GD&T.