R&D Engineer Medical Devices
Kelly Services
**_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_
**_Experience and Education_**
+ _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_
_Applicants must be legally permitted to work in the United States immediately and without employer sponsorship._
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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Engineering/Technology – Project Services?
Looking to work with leading project management organizations at top companies around the world? That’s where we come in. At Kelly Engineering and Kelly Technology, our Project Services Teams create expert talent solutions to solve the world’s most critical challenges. We connect you with opportunities to work on intriguing, innovative, and high-visibility projects—all with a schedule that works for you. Do you prefer the variety and flexibility of short-term projects? Or are looking for a long-term opportunity? Either way, our connections and expertise will help you take your career exactly where you want to go. That’s just good planning.
About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
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