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Medical Device Engineer in Thousand Oaks, CA at Apex Life Sciences

Date Posted: 11/21/2018

Job Snapshot

Job Description

A large medical device company in Thousand Oaks, CA is searching for a Senior level Medical Device Engineer to help with the development of a new combination product. Ideal candidates must possess a Bachelor's Degree and have at least 5 years of experience in a highly regulated industry; medical device experience is strongly preferred. This role is starting out as a 1 year contract.

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 development of 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, design transfer, regulatory submissions, and commercialization of these devices and combination products. 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. 

Job Responsibilities:

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

Required Skills: 

  • BS in Mechanical Engineering and previous experience in a medical device, or similar industry, with 5 - 10 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 and combination products.
  • 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.
  • 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.

  • 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


EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.