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Irvine, California Apex Systems
Excellent opportunity for a Mechanical Engineer to work in the medical device industry coordinating with R&D and Manufacturing to ensure designs meet standards and functionality.

Duties :
  • Coordinate with R&D to ensure functionality and manufacturability of designs.
  • Design sub-assemblies to meet broad design goals, establish requirements and specifications.
  • Use empirical, numerical and experimental analysis to analyze designs.
  • Develop and validate test methods and models.
  • Identify and mitigate sub-assembly risks.
  • Support invention disclosures.
  • Work with internal departments and external vendors to obtain prototype parts and to understand their capabilities and limitations.
  • Support pre-clinical and clinical testing of devices.
  • Support design reviews and physician visits.
  • Gain a detailed understanding of the developing clinical environment (i.e. current and emerging treatment methods, evolving clinical needs etc.).
  • Gain a detailed understanding of the quality and regulatory requirements of Abbott, FDA and ISO regulations, managing projects within these requirements.
  • Gain a detailed understanding of overall scheduling, managing time and tasks within a defined schedule.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Education and Experience
  • Bachelors Degree in Mechanical or Biomedical engineering, or an equivalent combination of education and work experience.
  • Minimum 3 years work experience (medical device experience preferred)

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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 or - provided by Dice