Edwards Lifesciences Principal Supplier Component Engineer (Onsite) in Irvine, California
At Edwards Lifesciences our continued mission is to be reliable, agile, innovative, and patient-focused in providing the highest quality, industry-leading products and solutions to our customers. Join a diverse team of passionate professional with a Patients first work culture in a rapidly growing organization. With its strong focus on employee wellbeing and culture of continued learning and improvement, Edwards is a perfect place to grow and launch your career.
The Principal Supplier Component Engineer will directly support the design and development teams in qualifying critical materials and suppliers in support of launching innovative & life-saving medical devices. This individual will facilitate compliance to applicable internal and external requirements. You will work in a fast-paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success. This role will work in close partnership with R&D, Marketing, Operations, Sourcing, and RA.
Essential Responsibilities :
Identify and implement inspection controls to support the development and qualification of purchased components. Ensure validation methods of critical suppliers and incoming quality control are aligned with international standards, global regulations, and Industry best practices.
Support completion of Design File requirements applicable to supplied components, subassemblies, devices, and services.
Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations and develop reports
Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and collaborate with team members to drive project completion
Lead in the identification and ensure the optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
Lead the development of process controls for CTQs and parameters
Develop technical content of risk management files
Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.
Train, coach, and guide lower-level employees on more complex procedures
Ability and willingness to travel between 10 – 25% domestically and internationally
Other incidental duties as needed
Required Education & Qualifications :
Bachelor’s degree in Engineering or Scientific field with 6 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality engineering functions; OR a Master’s degree in Engineering or Scientific field with 6 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality engineering functions.
Well-versed in statistical tools such as Gage R&Rs, control charting, or statistical process controls
Demonstrated Project Management experience
Experience with supplier/vendor management and qualification activities with new suppliers, CMOs (Contract Manufacturing Organizations), or OEMs for new products.
Experience with CAPAs, NCRs, Change Notifications, and/or Auditing
Demonstrated experience driving component testing, test method validations, and testing/validating equipment
In-depth understanding and experience with risk management for validation qualifications (e.g. equipment or process OQ/PQs).
Knowledge of manufacturing process for molds, machining, or textiles
Knowledge and understanding of FDA and international regulatory standards (i.e. ISO 13485 & ISO 14971) for medical devices.
Six Black Belt or Quality Engineer Certified
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.
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