About the position
Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our New Product Development Engineering team, you will work closely with our R&D and Quality teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around 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. This is an exciting opportunity for a Sr. Engineer to support the launch of a next generation device within THV. This role provides the opportunity to collaborate with sites both internationally and domestically.
Responsibilities
- Driving cross-functional coordination to ensure milestones regarding product builds, validations, etc. are met.
- Direct process development and characterization for Early Human Use, Clinical, and Commercial device releases using DMAIC methodologies.
- Identifying and ensuring implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standards.
- Developing complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports.
- Developing training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
- Overseeing manufacturing support tasks; giving instruction to technicians on conducting tests; training technicians and providing feedback; and coordinating technician work.
Requirements
- A Bachelor's degree in Engineering or Scientific field with 4 years of previously related industry experience OR Master’s degree in Engineering or Scientific field with 3 years of previously related industry experience.
Nice-to-haves
- Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred.
- Strong 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 preferred.
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
- Strong problem-solving, organizational, analytical and critical thinking skills.
- Substantial understanding of processes and equipment used in assigned work.
- Good leadership skills and ability to influence change.
- 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.
- Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.
Benefits
- Competitive salaries
- Performance-based incentives
- A wide variety of benefits programs to address the diverse individual needs of our employees and their families.
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