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 R&D Engineering team, you will work closely with our Quality and Manufacturing 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. The Engineer II is part of the THV R&D implant development team. The role of the team is to design, develop and set up manufacturing processes of valves that are best in class to achieve the THV R&D group mission. The team is also a strong partner with the Global Supply Chain & Operations group in order to launch these innovations to help patients. The position specifically will focus on pre-commercial R&D manufacturing and process development.
How you’ll make an impact:
Create, test, and/or improve products by developing moderately complex experiments and tests , analyze results, make recommendations, and develop reports, based on engineering principles
Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills
Generate work instructions, test methods, engineering drawings/prototypes, etc. to establish/characterize product and/or process specifications
Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
Create/update portions of design control documents including requirement specs and risk documents
Assign R&D & Manufacturing support tasks; gives instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers
What you'll need (Required):
Bachelor's Degree in Engineering or Scientific field, 2 years 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):
CQE (Certified Quality Engineer), if applicable
Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
CAD experience in Solidworks or CREO
Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Basic understanding of statistical techniques
Solid problem-solving, organizational, analytical and critical thinking skills
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
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
Ability to build productive internal/external working relationships
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
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $87,000 to $123,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.