Edwards Lifesciences

Develops transcatheter heart valves and devices

Engineer 2 - Manufacturing

Manufacturing EngineeringConfirmed live in the last 24 hours

Full-timeSalt Lake City, UT, USANo salary listedIn-person

About the Job

Requirements

A Bachelor's degree in Engineering or a Scientific field and two years of related experience, or a Master's degree or equivalent with internship, senior project, or thesis experience in an Engineering or Scientific field, including industry or industry/education experience.
Lean Six Sigma certification is preferred.
PMP certification is preferred.
Experience in the medical device industry or another highly regulated manufacturing environment is preferred.
Experience with Root Cause Analysis, Nonconformance Reports, and Corrective and Preventive Actions is preferred.
Computer skills using Microsoft Office Suite, including Microsoft Project, and CAD experience are preferred.
Documentation, written and verbal communication, interpersonal relationship, consultative, and relationship management skills are preferred.
Basic understanding of statistical techniques is preferred.
Understanding of principles, theories, and concepts relevant to Engineering is preferred.
Problem-solving, organizational, analytical, and critical thinking skills are preferred.
Understanding of processes and equipment used in assigned work is preferred.
Attention to detail is preferred.
Ability to interact professionally with all organizational levels is preferred.
Ability to manage competing priorities in a fast-paced environment is preferred.
Ability to work in a team environment and manage vendors and project stakeholders is preferred.
Must follow company rules and requirements, including pandemic protocols and Environmental Health and Safety rules, and take adequate control measures to prevent injuries and pollution within their span of influence or control.

Responsibilities

Optimize manufacturing processes using engineering methods such as Six Sigma and Lean methods for continuous process improvement, and redesign or design equipment, tools, and fixtures to improve processes using technical design skills.
Use root cause analysis tools to solve moderately complex process issues.
Develop moderately complex experiments and tests, including writing and executing protocols, to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
Troubleshoot simple mechanical systems and diagnose in-line equipment issues when they arise.
Analyze and resolve moderately complex compliance issues, including corrective and preventive actions, non-conformances, and audit observations.
Develop training and documentation materials, including work instructions, for production to transfer project and manufacturing process knowledge.
Establish project plans to ensure deliverables meet customer expectations using project management tools such as project plans and risk analyses.
Oversee manufacturing support tasks, instruct technicians conducting tests, train technicians and provide feedback, and coordinate technician work.
Partner with Quality, Complaints, Operations, and New Product Development groups to solve day-to-day manufacturing problems.
Perform other incidental duties assigned by leadership.

Desired Qualifications

Lean Six Sigma certification.
PMP certification.
Experience in the medical device industry or another highly regulated manufacturing environment.
Experience with Root Cause Analysis, Nonconformance Reports, and Corrective and Preventive Actions.
Computer skills using Microsoft Office Suite, including Microsoft Project, and CAD experience.
Documentation, written and verbal communication, interpersonal relationship, consultative, and relationship management skills.
Basic understanding of statistical techniques.
Understanding of principles, theories, and concepts relevant to Engineering.
Problem-solving, organizational, analytical, and critical thinking skills.
Understanding of processes and equipment used in assigned work.
Attention to detail.
Ability to interact professionally with all organizational levels.
Ability to manage competing priorities in a fast-paced environment.
Ability to work in a team environment and manage vendors and project stakeholders.

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives.

This Engineer II will play a key role in supporting and sustaining the manufacture of THV delivery systems while driving continuous improvement initiatives across the production environment. In collaboration with cross-functional partners, they will identify opportunities to enhance manufacturing processes, improve product quality and reliability, and increase operational efficiency to support business and patient needs.

How you'll make an impact:

Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills
Use Root Cause analysis tools to solve moderately complex process issues
Develop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
Troubleshoot simple mechanical systems, and ability to diagnose in-line equipment issues if they arise
Analyze and resolve moderately complex Compliance issues (e.g., CAPA, non-conformances, audit observations
Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
Establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
Partner with cross-functional groups like Quality, Complaints, Operations and NPD to solve day to day manufacturing problems
Other incidental duties assigned by Leadership

What you'll need (Required):

Bachelor's Degree in Engineering or Scientific field with 2 years of related experience OR
Master's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education

What else we look for (Preferred):

Lean Six Sigma certification
PMP certification
Experience working in the medical device industry or another highly regulated manufacturing environment
Experience with Root Cause Analysis (RCA), Nonconformance Reports (NCRs), and Corrective and Preventive Actions (CAPAs)
Good computer skills in usage of MS Office Suite including MS Project; CAD experience
Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Basic understanding of statistical techniques
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
Solid problem-solving, organizational, analytical and critical thinking skills
Solid understanding of processes and equipment used in assigned work
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 the ability to manage vendors and project stakeholders
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.

About the Company

Edwards Lifesciences

Develops transcatheter heart valves and devices

Edwards Lifesciences focuses on cardiovascular medical technologies, especially transcatheter heart valves. Its products enable repairing or replacing diseased heart valves through minimally invasive procedures rather than open-heart surgery. The company builds on a long history that began with the Starr-Edwards valve and now centers on valve therapies and related diagnostics to treat heart disease. It differentiates itself by specializing in valve technologies and transcatheter approaches, backed by a track record of clinical leadership and global reach. The goal is to improve patient outcomes by providing safer, less invasive valve treatment options for people around the world.

Company size: 10,001+
Company stage: IPO
Headquarters: Irvine, CA
Founded: 1958

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