Quality Engineer I, NPD

Edwards Lifesciences Gruppe; Draper (UT); On-site; USD 70,000 - 100,000; Full time

Job summary

Edwards Lifesciences seeks a manufacturing engineer to optimize production processes and support design control activities. You will develop essential manufacturing documentation and training materials and collaborate on process definitions and controls.

Responsibilities include supporting equipment engineering, root-cause investigations, CAPA, and validations. A strong foundation in LEAN, statistics, and documentation is required.

Qualifications

• Bachelor’s degree in engineering or a scientific field is required.
• Experience with manufacturing documentation and process control is preferred.
• Familiarity with LEAN principles and basic statistics is advantageous.

Responsibilities

• Support design control activities related to manufacturing product and process.
• Develop manufacturing documentation (drawings, SOPs, routers, pFMEA) and training materials for production.
• Assist development of process definitions and process controls.
• Contribute to equipment engineering and tooling design for production.
• Collaborate on root cause investigations and CAPA for manufacturing processes.
• Apply LEAN methods and statistics for continuous process improvement.
• Support qualifications and validations (IQ, OQ, software) of manufacturing processes.

Skills

Manufacturing engineering

Process optimization

LEAN methods

Statistical analysis

Documentation skills

Cross-functional teamwork

CAPA knowledge

Education

Bachelor’s Degree in Engineering or Scientific field

Tools

MS Office

MS Project

CAD

Job description

Imagine how your ideas and expertise can change a patient’s 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. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s 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 patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. In 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 you’ll need (Required):

• Bachelor’s 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.