Senior Engineer, R & D
As a Senior Engineer, you will be responsible for verification and validation activities of disposable medical devices throughout the development process, including prototyping, proof-of-concept, and product launch. You will also be responsible for protocol writing and execution, including hands-on training of technicians and writing final reports. This position will be part of a cross-functional team that collaborates, develops, and manages projects related to class II disposable medical devices from proof-of-concept through world-wide launch.
We are looking for a creative thinker - someone who takes a logical approach to solving problems and the product development process.
In particular you can expect to:
- Interpret product requirements and develop appropriate test methods and acceptance criteria that verify requirements were met.
- Author and execute verification and validation protocols and reports using statistical tools and methods.
- Contribute to common risk management techniques (FMEA, FTA, ETA).
- Use statistical techniques to analyze, summarize, and communicate test results and data.
- Conduct experiments using common DOE and statistical analysis tools.
- Support planning and execution of Human Factors studies to ensure design meets user needs and reduces use errors.
- Design, execute, and interpret experiments, including basic aptitude in statistics.
- Design components, assemblies and test fixtures utilizing 3-D modeling (SolidWorks).
- Participate in periodic design reviews of projects.
You will have the opportunity to:
- Improve patient outcomes
- Meaningfully impact the company’s short-term and long-term success
- Work closely with executives across the organization
- Grow your role as you see fit
- Learn everything there is to know about respiratory medical device product development
- Create an inspiring workplace
To be successful, you will need:
- 4-6 years relevant work experience.
- Experience with medical product development or other highly regulated environments highly preferred (ISO requirements, GMP/GDP guidelines, FDA regulations, International regulation, and medical device design control).
- Working knowledge of international standards applicable to medical devices, including ISO13485, ISO14971, and IEC60601 and its collateral standards.
- Experience working with engineering and other professionals in a cross-functional matrix organization.
- Work independently, a key problem solver and work with teams internally & externally to procure required materials and services.
- Team player by nature with the ability to work independently with a result-oriented ‘can-do’ attitude.
- Working knowledge and proficiency using SolidWorks for 3-D design & development, including the ability to create, interpret, and utilize 2-D drawings to capture specifications.
- Working knowledge of experimental design and statistical methods.
- B.S. in mechanical, plastics, biomedical engineering, or equivalent.
- The current office is based in Yorba Linda however we will be moving to the Irvine area. Once property is identified in Irvine, this position will relocate to the new space based in the Irvine area.