Senior Engineer in Thousand Oaks, CA at Apex Life Sciences

Date Posted: 11/7/2018

Job Snapshot

Job Description


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.

Skills:

  • BS in Engineering (preferably Mechanical, Electrical, Biomedical Engineering)
  • Minimum 3 – 5 years current relevant experience with medical devices design, design changes, processes and procedures.
  • Strong background in engineering and commercialization of electro-mechanical medical devices and/or drug/device combination products
  •  Experience with material & test specifications generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
  •  Experience with product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
    • 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        

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.




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