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.
Skills Required
- Bachelor's degree in Engineering or a scientific field
- Proficiency using Microsoft Office Suite
- Experience with Microsoft Project
- CAD experience
- Basic documentation, written and verbal communication, and interpersonal skills
- Basic understanding of statistical techniques
- Experience working with laboratory or industrial equipment
- Understanding of engineering principles, theories, and concepts
- Problem-solving, organizational, analytical, and critical-thinking skills
- Understanding of processes and equipment used in assigned work
- Knowledge of environmental health and safety and quality guidelines for cleanroom medical device manufacturing
- Ability to work in a team environment and interact professionally across organizational levels
- Ability to manage competing priorities in a fast-paced environment
Edwards Lifesciences Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.
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Healthcare Strength — Health coverage is considered strong, with multiple plan choices, HSA options, and fertility support, and the company highlights holistic well‑being programs.
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Retirement Support — A company 401(k) match and well‑regarded retirement offerings add clear long‑term value to total compensation.
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Equity Value & Accessibility — An Employee Stock Purchase Plan with a discount and look‑back feature makes equity ownership accessible and enhances the total rewards package.
Edwards Lifesciences Insights
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
