Engineer

Location: Thousand Oaks, CA
Date Posted: 09-15-2016
Job Description
Support project teams in the development of drug delivery devices. Scope includes a wide range of devices, such as needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will support technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The 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 Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

Responsibilities
  • Work cross-functionally with individuals and within project teams.
  • Create and assess product requirements to determine technical coverage and proper integration different subsystems.
  • Perform design analyses and assessments.
  • Execute design characterization and design verification testing.
  • Develop, execute, and review design documents, specifications, development plans, characterization plan, verification plans, reports, and other related product development documents for assigned projects.
  • Provide technical assistance to projects.

Skills
  • BS in Mechanical Engineering and previous experience in a medical device, or similar industry, with 2 - 6 years current experience with engineering processes and procedures.
  • Participation in development projects from concept through the 510k and PMA approval process.
  • Strong background in engineering of electro-mechanical and disposable medical devices.
  • Ability to model and analyze mechanical systems, fluid flow, stress, assemblies, structures, linkages, heat transfer and other mechanical engineering specialties.
  • 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.
  • Familiarity with the following standards
    • 21CFR820 Quality System Regulation
    • ISO 14971 Risk Management
    • EU Medical Device requirements
    • Medical Devices Directive 93/42/EEC
    • Medical Electrical Equipment
    • EN 60601
  • 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.
  • Plastic part design experience is a plus.
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