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Engineer (Medical Device)

Astrix Technology Group Los Angeles, CA Contractor
$127,261.00 (Careerbuilder est.) What is the Careerbuilder Estimated Salary? Only about 20% of the jobs in our search results contain salary information. When a job posting doesn’t include a salary, we estimate it by looking at similar jobs in the same industry in that location. It is not necessarily endorsed by the employer and actual compensation may vary based on your experience.
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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
Engineering
Quality Management Systems
Process Development
Iso 13485
Corrective And Preventive Action (Capa)

Location

CareerBuilder Estimated Salary What is the Careerbuilder Estimated Salary? Only about 20% of the jobs in our search results contain salary information. When a job posting doesn’t include a salary, we estimate it by looking at similar jobs in the same industry in that location. It is not necessarily endorsed by the employer and actual compensation may vary based on your experience.

x

What is the Careerbuilder Estimated Salary?

Only about 20% of the jobs in our search results contain salary information. When a job posting doesn’t include a salary, we estimate it by looking at similar jobs in the same industry in that location. It is not necessarily endorsed by the employer and actual compensation may vary based on your experience.
This estimation is based on Job title, Industry, Location and Skills
$127,261
Avg. Yearly Salary
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