Sr Engineer

Thousand Oaks, California | Contract

Post Date: 02/10/2015 Job ID: 439

Lead or support 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 lead or support technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Senior 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 Senior 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 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 with 2 - 10 years current experience with engineering processes and procedures.
  • Led or participated in projects from development through the 510k and PMA approval process.
  • Strong background in engineering and commercialization of electro-mechanical and disposable 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
  • 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 
  • 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. 
  • Plastic part design experience is a plus.
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