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Engineer (Medical Device)

Astrix Technology Group Los Angeles Contractor
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We are looking for Engineers with Medical Device, Biopharmaceutical and Biotechnology industry experience in the following disciplines: Quality/Product Quality, Mechanical Design, Manufacturing, Process Development and Electrical Engineering.

Title: Engineer or Sr. Enginer (Medical Device)

Engineering Discipline: Quality/Product Quality Engineering, Mechanical Engineering, Manufacturing Engineering and/or Validation Engineering

Contract Duration: 12 - 36 months (potential extension or permanent conversion)

Responsibilities (heavily dependent on titles and departments):

  • Support production projects and process improvements (trend analysis, process validation, SPC).
  • Support Quality Systems (perform audits, SOP improvement, training, CAPA investigations).
  • 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.
  • Manufacturing procedure development, manufacturing test procedures, engineering changes (ECN), process optimization experience.

Skills Required:

  • BS in Engineering (preferably Mechanical, Electrical, Biomedical Engineering)
  • Minimum 2 - 10 years current relevant experience with medical device, device design process, quality engineering and/or manufacturing engineering.
  • Experience with material & test specifications generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
  • Strong background in SolidWorks (3D modeling).

Preferred Background:

  • Background in engineering and commercialization of electro-mechanical medical devices and/or drug/device combination products.
  • Experience with product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
  • Experience with Process Development.
  • CAPA and Risk Management.
  • Familiar with Quality System Regulation 21CFR820.
  • Familiar with ISO 13485.

Recommended skills

Failure Mode Effects Analysis
Quality Management Systems
Process Development
Iso 13485
Corrective And Preventive Action (Capa)
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