Sr Engineer

Location: Thousand Oaks, CA
Date Posted: 11-10-2016
Job Details
Lead quality efforts in the development and sustaining of drug delivery devices. Scope includes a wide range of devices, such as; prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. This position is part of the company's Device Quality organization, and will be responsible for technical device design aspects of quality work, but in development and sustaining activities. The qualified candidate will employ quality principles and procedures to ensure development and sustaining of these mechanical and electro-mechanical medical devices complies with applicable regulations and standards. The Senior Engineer will work within cross-functional project teams to develop and maintain detailed engineering specifications, support device design & development, verification, validation, and regulatory submissions of these devices. The role of the Senior Engineer is to work within a cross-functional organization to provide technical expertise and represent Quality functions and needs.

Desired Qualifications
  • BS in Engineering and previous experience in medical device industry
  • 5 years experience in quality function.
  • Strong communication skills.
  • 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 and 21CFR Part 4
    • Risk Management ISO 14971
    • EU Medical Device requirements - Council Directive 93/42/EEC
    • Medical Electrical Equipment - EN 60601 - Small scale device assembly experience.
  • Must be capable of working on multiple projects in a deadline driven environment.
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