We are currently looking for several Development Engineers to support out Medical Device DHF Remediation Project in the greater Ft. Myers, FL area. These individuals will be responsible for all of the following, but not limited to:
* Contribute to completion of documentation
* Review documentation for Content and Quality
* Act as final EASi review before documents are sent for further review
* Work for Project Manager and team to develop schedule estimates
* Manages daily activities of team members and provide support where needed
* Help monitor team's progress toward schedule commitments
In order to be considered, the ideal candidate needs to meet all of the following qualifications:
* Minimum of 3-5 years of Design Engineering experience; specifically with Design Controls and Planning
*Bachelor of Science in Mechanical Engineering and/or Biomedical Engineering
* Design Reviews
* Design Tranfers
* Design History Files preferred
* Must have Medical Device industry
* Must have 21CFR820 experience
* Must have ISO13485
* 3D CAD Software : Solidworks, Pro/E
* Verification and validation experience to demonstrate product safety and efficacy
* Determine testing required to satisfy product requirements
* Experience with FMEAs, investigate potential failure modes and address project design inputs
* Develop protocols
* Plan, perform and monitor testing
* Utilize statistical methods for DOE (Design of Experiments) and plan testing to analyze results
* Write reports and draw conclusions
* Ability to satisfy companies quality manual with emphasis on design control
* Ability to conduct design reviews and facilitate technical meetings
Amazing begins here. EASi is a leading global services company specializing in engineering and sciences. For more than 35 years, EASi has delivered critical services across a range of industries, including energy and utilities, transportation, heavy equipment, consumer and industrial products, medical devices, pharmaceutical and biotechnology, as well as academic and health care research. By adapting to the constantly evolving needs of our customers, we have built specialized expertise and a multidisciplinary perspective - leveraging cutting-edge technology and processes - to constantly improve and innovate. Through EASi's flexible solutions and consultative approach, customers in engineering and sciences can expect unparalleled quality, increased speed to market and collaborative customer engagement services.
Headquartered in Hanover, Maryland, EASi has 3,700 dedicated employees across North America, Europe and Asia. EASi is an Aerotek company, a leader in the recruiting and staffing industry. Aerotek is an operating company of Allegis Group® Inc., a global leader in talent solutions. To learn more about EASi, visit EASi.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
creo elements/pro (computer-aided design software)
verification and validation (software)
iso 13485 standard
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