Quality Engineer I, NPD

Imagine how your ideas and expertise can change a patients life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. Youll bring your passion for problem solving and partner with various teams to influence decision-making for a products entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patients unmet clinical needs. Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring this role you will apply your knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.

How you will make an impact:
Support design control activities related to manufacturing product and process.

Develop documentation related to manufacturing (i.e. drawings SOP routers pFMEA) at various levels of release. Develop basic training and documentation materials (e.g. work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
Support creation of process definition / development of process controls.
Support specifications from an operations perspective (i.e. DFx tolerancing material selection automation) supporting the establishment of stability metrics and elevating / mitigating risks through SCRR MRR
Collaborate build strategy prioritization and build technical support for QST pre DV DV Partner with Pilot on root cause investigations for manufacturing processes (prior to commercialization)
Support development of basic experiments and tests (including writing and executing protocols) to characterize and develop processes. Support qualifications and validations (IQ OQ Software) of manufacturing processes.
Support manufacturing equipment engineering and tooling design (Program Specific)
Collaborate in the analysis of basic Manufacturing and Compliance issues (e.g. CAPA non-conformances audit observations) and provide technical support in process transfer.
Identify opportunities for re-design/design of basic equipment tools fixtures etc. to improve manufacturing processes
Improve manufacturing processes using engineering methods (e.g. LEAN methods basic statistics) for continuous process improvement
Other incidental duties assigned by Leadership

What youll need (Required):
Bachelors Degree in Engineering or Scientific field

What else we look for (Preferred):
Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
Basic documentation communication (e.g. written and verbal) and interpersonal relationship skills
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment preferred (if applicable)
Good understanding and knowledge of principles theories and concepts relevant to Engineering
Good problem-solving organizational analytical and critical thinking skills
Good understanding of processes and equipment used in assigned work
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment including immediate supervisor and other team members in the section or group; and may interact with vendors
Ability to build stable working relationships internally
Adhere to all company rules and requirements (e.g. pandemic protocols Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.