Icon hamburger
US
What job do you want?
Apply to this job.
Think you're the perfect candidate?
Apply Now
Thumsup

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.
I2r0mq77nqr69bx6s6k

Engineer II

Apex Systems Irvine Contractor
Apply Now

Large medical device company in Irvine is seeking Design Engineers to join their team!

Responsibilities:

  • Transfer product/Processes from R&D to Manufacturing using project management, design for manufacturability and cost, process/design excellence, LEAN, ergonomics and knowledge transfer methodologies to ensure effective implementation of equipment, processes, and new technology
  • Development of process specifications which ensure user needs are met
  • Perform Equipment and process qualifications (CD/IQ/OQ/PQ)
  • Collaborate with cross functional team to meet project deliverables.
  • Accountability (including hands on and resourceful) on troubleshooting, problem solving, and escalation of program risk to management when design transfer and scale-up to manufacturing do not work as expected


Skills:

  • Experience with key technologies and processes related to the assembly and manufacture of heart valves, surgical instruments, stents, catheters, delivery systems, and/or interventional devices is preferred.
  • Experience with use of process and design excellence methodologies including Six Sigma.
  • Familiarity with Design for Manufacturability, and LEAN experience leading to manufacturing efficiency improvement.
  • Ability to develop process specifications, collaborate with outside design firms and work with Operations personnel.
  • Knowledge of cGMP, EHS guidelines, FDA guidelines, and Process Validation.
  • Capable of analyzing and solving complex problems through innovative thought and experience.
  • Strong verbal/written communication and interpersonal skills including conflict and relationship management.


Education:

  • A Bachelor's degree in engineering discipline is required; preferably Mechanical, Biomedical, or Chemical Engineering.
  • A minimum of 2  years of experience in medical device manufacturing is required.

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 844-463-6178

 

Recommended skills

Operations
Engineering
Interpersonal Skills
Manufacturing
Management
Analysis
Apply to this job.
Think you're the perfect candidate?
Apply Now

Help us improve CareerBuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team

Job ID: 997696

CAREERBUILDER TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.