What are the responsibilities and job description for the Principal Engineer, Pilot position at Edwards Lifesciences?
Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.
The mission of Irvine Pilot Operations is to enable Edwards to achieve rapid product development cycles coupled with exceptional product reliability, efficient cost, and real-time product transfers through a strong partnership with the NPD teams and the global plant network.
How you’ll make in impact :
Lead and support Pilot initiatives to implement manufacturing best practices and production transfer.
Provide manufacturing engineering support in the design and development of delivery systems and accessories used to treat cardiovascular disease. Conduct engineering activities from early product development through product launch and transfer.
Develop manufacturing capability to meet requirements including procurement, development, and qualification of manufacturing equipment. Develop manufacturing processes and procedures (JDOC and MES). Conduct studies to characterize new manufacturing processes. Develop and execute process validation plans.
Conduct design / process reviews and apply DFM concepts and principles to ensure DFM considerations are incorporated into designs. Deploy Lean concepts and principles into line and workstation designs.
Develop and implement process improvements to stabilize new production processes. Drive product quality through risk control measures and process control.
Develop and execute operations strategy to integrate new products into manufacturing. Manage product design iterations around regulatory and clinical requirements. Support manufacturing readiness reviews and complete design transfers to manufacturing.
What you’ll need :
Bachelor's degree in engineering field such as mechanical engineering, biomedical, or manufacturing engineering or in scientific.
6 years of manufacturing engineering experience in the medical device industry.
What else we look for :
Medical device manufacturing experience in heart valves, stents, catheters, nitinol stents, delivery systems and / or interventional access devices.
Understanding of statistical techniques is required, and Six Sigma Black Belt Certification.
Familiarity with Design for Manufacturability and LEAN.
Effective communication skills.
Ability to work well both independently and as a member of a team is essential.
Strong analytical, problem solving and technical writing skills
CAD experience using Solidworks.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $118,000 to $167,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity / Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
Salary : $118,000 - $167,000
