
Description
Kelly Engineering is seeking an R&D Engineer II for a long-term contract at one of our Global Medical Device clients, located in Irvine, CA.
Our Client is a global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide
As a Kelly employee, you will be eligible for Medical & Dental 50% paid, 401K and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation and sick/personal time. All KellyOCG employees receive annual performance reviews.
R&D Engineer II Job Description
The Research & Development Engineer will be supporting project teams in the development of electrophysiology catheters and systems. Project support includes overall design, requirement development, design for manufacturing, test method development, and product verification and validation testing.
- Support engineering by researching, designing, developing, and testing according to established policies, procedures, government and compliance regulations, and customer requirements
- Build prototypes and work with lab technicians to build prototypes
- Develop test fixtures and test methods
- Perform failure analysis using established analysis tools
- Documentation in a laboratory notebook and generation of formal test reports
- Data analysis of various system logs, including generators and Carto 3 system
- Interface with external vendors and internal cross-functional partners
- Creation of work instructions, design drawings and procedures
- Limited travel to customer sites, domestic, to gather VOC, perform testing and/or perform troubleshooting activities
- Participation in pre-clinical assessments of design concepts, in the laboratory and in an OR environment, with a cross-functional team
- Support the design reviews and pre-validation assessments to ensure the safe and efficacious design and processes
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
- Will work as part of a team and must be able to work somewhat independently for individual tasks
- Knowledge and skills to satisfactorily develop the responsibilities of the position
- 2 to 4 years of experience related to the position
- University/Bachelor's Degree in Mechanical or Biomedical Engineering or Equivalent
- Candidate who is independent, innovative and highly motivated
- Ability to travel domestic 10%.
- Medical device Class II and III experience preferred.
- Knowledge and experience in product development processes
- Experience with statistical analysis and design of experiments (DOE) preferred
- Ability to solve complex problems is preferred
- Ability to communicate effectively, both in writing and verball
- Familiarity with quality and regulatory systems including FDA's Quality System Regulation, ISO13485
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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