Senior R&D Engineer (Onsite Irvine, CA)

Stryker•Irvine, CA

6d•Onsite

About The Position

The Senior R&D Engineer supports project teams in the development of medical devices. This includes writing or verifying specifications, developing testing and product processes, and designing fixtures, to ensure the concepts and/or prototypes meet requirements. Under minimal supervision; research, design, develop, modify, and verify components/modules for medical device product development and/or misc. activities. Translate and/or define design inputs to engineering specifications and produce sub-system level designs. Apply fundamental and some advanced concepts, practices and procedures to problem solving. Demonstrate advanced understanding of customer needs and design inputs. Demonstrate proficiency with product’s intended use and clinical procedures. Learn how the financial models are constructed. Follow fundamental industry standards, design requirements, and test strategies which apply to regulatory requirements. Independently create or refine engineering documentation, such as the Design History file. Follow R&D procedures like design controls and risk management, per the Quality Management System. Collaborate with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.

Requirements

Bachelor of Science Degree in Engineering; Mechanical Engineering or Biomedical
2+ years of relevant work experience.

Nice To Haves

Master of Science Degree in Engineering, Mechanical Engineering or Biomedical
Working knowledge and understanding of mechanical engineering practices and design principles within 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.

Responsibilities

Research, design, develop, modify, and verify components/modules for medical device product development and/or misc. activities.
Translate and/or define design inputs to engineering specifications and produce sub-system level designs.
Apply fundamental and some advanced concepts, practices and procedures to problem solving.
Demonstrate advanced understanding of customer needs and design inputs.
Demonstrate proficiency with product’s intended use and clinical procedures.
Learn how the financial models are constructed.
Follow fundamental industry standards, design requirements, and test strategies which apply to regulatory requirements.
Independently create or refine engineering documentation, such as the Design History file.
Follow R&D procedures like design controls and risk management, per the Quality Management System.
Collaborate with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.