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