Sustaining R&D Engineer II
Orange County Metro Area, CA
Life Sciences Industry
The Sustaining R&D Engineer is a key technical role that supports manufacturing sites and divisional functions. This position is responsible for owning existing product designs for Critical Care Operations Engineering. This person will guide the establishment and evaluation of test criteria and test method development to establish the device performance. This person will collaborate within a cross-functional team to define and accomplish the development and validation strategies.
Key responsibilities include:
- Development of new test methods to characterize design concepts.
- Conduct tests utilizing existing test protocols, or develop new ones as needed and generate related written reports with good documentation practices.
- Provide subject matter expertise in matters of design control for established Critical Care products.
- Answering questions from regulatory agencies during submissions to international countries.
- Perform other duties and responsibilities as assigned.
- A Bachelor s Degree in Mechanical or Biomedical Engineering with a minimum of 3 years of engineering experience; or Master s Degree in Mechanical Engineering. Other relevant engineering degrees will be considered.
- Experience generating and validating test methods.
- Experience with laboratory test measurement devices such as pressure transducers, flow sensors, electrical testing, and data acquisition software.
- Strong understanding of engineering fundamentals, and an ability to deconstruct real world issues into root engineering causes.
- Robust statistical skills and analytical thinking.
- Must be able to work with moderate supervision, think critically, and communicate effectively.
- Strong verbal and written communication skills are required.
- Traveling is 25%.