Senior Quality Engineer, Metals Process Engineering

Edwards Lifesciences•Salt Lake, UT

About The Position

Edwards Lifesciences is seeking a Senior Quality Engineer for their Metals Process Engineering Group (MPEG). This role will support the development of nitinol frames and implant components through various project phases including design verification, validations, launch and stabilize, and transfers to international sites. The engineer will be involved in advanced characterization, functional testing, and inspection development, applying a deep understanding of product development, risk management, process monitoring, and validation.

Requirements

Bachelor’s degree in Engineering or a scientific field with 4 years of relevant experience, or Master’s degree in Engineering or a scientific field with 3 years of relevant experience.
Ability to read and interpret drawings
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
Ability to translate technical information to all levels of the organizations
Knowledge of Six Sigma concepts with ability to apply to work product
Knowledge of Quality Engineering concepts with ability to apply to work product
Strong leadership skills and ability to influence change

Nice To Haves

Experience with manufacturing of metal implants, frames, stents, valves, delivery system components, or other precision implantable devices.
Experience supporting NPD/NPI programs, along with design verification, design validation, process validation, and product launch activities.
Supporting design transfer and manufacturing transfers.
Developing inspection strategies and test methods for implantable products.
Experience with pFMEA, dFMEA, process characterization, and process controls.
Experience using risk-based decision making throughout the product lifecycle.
Leading IQ/OQ/PQ and process validation activities.
Proven expertise in statistical techniques and SPC
Experience with automation, software testing, and software validation is strongly preferred

Responsibilities

Support or lead identification, development, and optimization of complex material characterization, testing methods, and inspection processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) for development of nitinol frame and component processes.
Implement advance process monitoring and statistical process control of complex processes to drive process control, capability and stability.
Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to validate and improve products (including evaluation of source materials and suppliers) and establish robust manufacturing processes/test methods based on engineering principles.
Ensure completion of comprehensive process validations (TMV/IQ/OQ/PQ), including analyzing results and developing reports.
Collaborate with cross-functional team members to facilitate project success and on-time completion.
Collaborate with engineers for equipment selection and validation.
Provide training and mentorship to enable the seamless knowledge transfer of project and manufacturing processes to receiving sites (Draper, Ireland, Singapore).
Develop technical content of risk management documentation and partner with DA and R&D engineers to ensure nitinol manufacturing considerations are incorporated into RMW, FMEAs, QCPs, etc.
Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., Material Review Board, SCAR, CAPA, non-conformances, audit observations) based on engineering principles; analyze results, make recommendations and develop reports.
Train, coach, and guide other quality engineers on complex principles.
Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.
Review and approve compliant change control.