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Principal Process Engineer, Technical Operations

Company: Edwards Lifesciences
Location: Irvine
Posted on: September 21, 2022

Job Description:

*Note: No pericardial tissue experience is required.*The Tissue Process Engineering Group (TPEG) in Technical Operations is responsible for the design, development, and implementation of next-generation pilot and commercial manufacturing processes and technologies used in the manufacture of bioprosthetic heart valves. The Principal Process Engineer would be responsible for supporting the development and rollout of the next-generation tissue chemical treatment technology at pilot and commercial scales.Key Responsibilities:+ Lead significant deliverables to develop and implement the pilot and commercial-scale chemical batch process from the ground up.+ Execute chemical scaleup studies to drive down costs/material usage and uncover/mitigate risks associated with process scaleup.+ Develop validation test plans at pilot and commercial scale and author well-written technical summaries and protocols/reports.+ Lead the identification and purchasing/development of off-the-shelf and custom processing and clean room equipment needed at pilot and commercial scales (CIP/SIP, mixing tanks, fume hoods, etc.).+ Leverage systems integration experience to lead the design and development of complex chemical equipment from URS development to build, testing, validation, and implementation into pilot and commercial production.+ Develop in-depth mechanical and software knowledge of the equipment under development and lead training sessions post-delivery.+ Serve as process and equipment SME and resolve technical issues during early phases of process launch.+ Support the transfer of projects to global sites as needed (Singapore, Costa Rica).+ Lead and establish complex project plans to ensure deliverables are completed to customer's expectations.+ Conduct process characterization and root cause analysis studies to improve equipment/process functionality.+ Establish effective communication channels for a wide network of stakeholders and frequently present to leadership forums.+ Perform other duties and responsibilities as assigned.Qualifications:+ Bachelor's Degree in Engineering or Scientific field with 6 years of manufacturing engineering experience OR Master's Degree in Engineering or Scientific field with 4 years of manufacturing experience.+ Travel Requirements are up to 10% during transfers.Preferred Qualifications:+ Experience with chemical process scaleup.+ Experience developing and implementing complex, automated chemical mixing/processing equipment in medical device space.+ Strong technical skillset in manufacturing engineering: design for manufacturability (DFM), EH guidelines, FDA guidelines, and process validation.+ Excellent problem-solving, organizational, analytical, and critical thinking skills.+ Effective written and spoken communication and interpersonal skills at all levels of employees, suppliers, and consultants.+ Six Sigma and Lean certifications would be desirable.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.

Keywords: Edwards Lifesciences, Irvine , Principal Process Engineer, Technical Operations, IT / Software / Systems , Irvine, California

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