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Sr Engineer
Ref No.: 18-07869
Location: Thousand Oaks, California
Position Type:Engg (T)
Start Date / End Date: 06/18/2018 to 03/13/2020
Our client, a leading fortune company is looking for a Sr. Engineer. This is for an initial duration of 9 months and is located in Thousand Oaks, CA
 
Top Skill Sets:
  • 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

Responsibilities:
  • Work cross-functionally with individuals and project teams in Marketing, Operations, and Development
  • Create and assess product requirements to determine technical coverage and proper integration different subsystems.
  • Create and execute to project plans and schedules
  • Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
  • Provide deep technical assistance for junior engineers.

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
  • 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.

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

Very Important Note:
  • Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!!
 
Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.