Manufacturing Engineer II, Transfer Engineering

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

Job summary

Edwards Lifesciences in Draper, UT is seeking a Transfer Engineering–Manufacturing Specialist to help transition new products into production. You will optimize processes, qualify manufacturing steps, and support line setup and process validation in a regulated medical device environment.

The role emphasizes hands-on manufacturing experience, knowledge of LEAN/Six Sigma, CAD and MS Project, strong documentation and communication skills, and the ability to manage multiple priorities in a

Qualifications

• Bachelor’s Degree in Engineering or Scientific field with 2 years of related experience.
• Master’s Degree or equivalent with internship, senior projects, or thesis in Engineering or Science.

Responsibilities

• Optimize manufacturing processes using SIX Sigma and LEAN methods.
• Develop and execute moderately complex experiments and tests to qualify processes.
• Analyze and resolve manufacturing and compliance issues (CAPA, non-conformances, audits).
• Create training and work instructions for production to transfer knowledge.
• Establish project plans and use project management tools to meet customer expectations.
• Oversee manufacturing support tasks, train technicians, and coordinate work.

Skills

Lean manufacturing

Six Sigma

Project management

Analytical thinking

Documentation

Communication skills

Statistical techniques

Industrial equipment knowledge

Education

Bachelor's Degree in Engineering or Scientific field

Master’s Degree or equivalent with internship/thesis in Engineering or Science

Tools

MS Project

CAD

MS Office Suite

Job description

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. Join us and be part of our inspiring journey.

The Transfer Engineering team is responsible for transitioning new products into manufacturing through line setup, equipment qualification, process validation, launch readiness, and production stabilization.

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
• Develop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
• Analyze and resolve moderately complex Manufacturing and 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
• Other incidental duties assigned by Leadership

What you’ll need (Required):

• Bachelor’s Degree in Engineering or Scientific field with 2 years of previous 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):

• Hands on manufacturing and/or equipment experience
• Experience or exposure with process validations
• 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
• Previous experience working with lab/industrial equipment
• 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
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of applicable FDA regulations for medical device industry
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• 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.