Senior R&D Engineer (Onsite Irvine, CA)

TheSenior R&D Engineer supports project teams in the development of medical devices. Thisincludes writing or verifying specificationsdeveloping testingandproduct processesanddesigning fixtures to ensure the concepts and/or prototypesmeet requirements.

What You Will Do

• Under minimal supervision; research design developmodify and verify components/modules for medical deviceproduct development and/or .

• Translateand/or definedesign inputs to engineering specifications and produce sub-system level designs.

• Apply fundamental and some advanced concepts practices and procedures to problem solving.

• Demonstrateadvancedunderstanding of customer needs and design inputs.

• Demonstrateproficiencywithproductsintended use and clinical procedures.

• Learn how the financial models are constructed.

• Follow fundamental industry standards designrequirementsand test strategies which apply to regulatory requirements.

• Independently create or refine engineering documentation such as the Design History file.

• Follow R&D procedureslike design controls and risk managementperthe Quality Management System.

• Collaborate with R&D Quality Manufacturing Regulatory ClinicalMarketingand Project Management to ensure project success.

What You Need (Required Qualifications)

• Bachelorof ScienceDegree in Engineering; Mechanical Engineering or Biomedicalplus2 years of relevant work experience.

Preferred Qualifications (Strongly Desired)

• Masterof ScienceDegree in Engineering Mechanical Engineering or Biomedical preferred.

• Working knowledge and understanding of mechanical engineering practicesanddesign principleswithin a regulated environment.

• Technical ability to create engineering drawings and models applying GD&T and CAE tools.

• Demonstrated ability to apply knowledge of materials and manufacturing processes to product design.

• Knowledge of Machine Shop and 3D printing practices.

• Knowledge of Medical Device Manufacturing.