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Sr. Engineer
Ref No.: 18-13188
Location: Thousand Oaks, California
Position Type:Engg (T)
Start Date / End Date: 09/17/2018 to 09/16/2020
Our client, a leading biopharmaceutical company is looking for a Sr. Engineer. This is for an initial duration of 24 months and is located in Thousand Oaks, CA
 
Top Skill Sets:
  • Need a candidate with sharp device and validation requirement protocols.
  • FDA regulation 21CFR820, i.e. QSR, GMP, Design Control
  • Familiar with Risk Management Design/Process/Use FMEAs
  • Design for Six Sigma (DFSS) MSA, and Design Capability
  • Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!!
 
Description:
  • The Sr. Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices.
  • The role of the Sr. Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.
 
Skills:
  • BS in Engineering and previous experience in a medical device industry
  • 5-7 years current experience with engineering processes and procedures.
  • Led projects from development through the 510k and PMA approval process.
  • Strong background in engineering and commercialization of electro-mechanical medical devices.
  • Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
  • Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
  • Experience in drug/device combination product design and development
 
Familiar with the following standards:
  • Quality System Regulation 21CFR820
  • Risk Management ISO 14971
  • EU Medical Device requirements Council Directive 93/42/EEC Medical Electrical Equipment EN 60601
  • Small scale device assembly experience.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
  • Strong problem solving, risk assessment, and risk management skills.
  • Must be capable of working on multiple projects in a deadline driven environment.
 
Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.