- Create, test, and/or improve products by developing complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles
- Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications
- Create/update more complex design control documents including requirement specs, and risk documents
- Develop and execute engineering project plans
- Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers
- Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
- Evaluate input and form a technical recommendation including designing parts, components and subsystems
- Train, coach, and guide lower-level employees on routine procedures
- Other duties assigned by Leadership
- Bachelor's degree in Engineering field and 4+ years' experience in medical device - OR
- Master's degree in Engineering and 3+ years' experience in medical device - OR
- Strong communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
- Working understanding of statistical techniques
- Strong problem-solving, organizational, analytical and critical thinking skills
- Experience integrating multiple devices or processes and understanding how they work as a single system
- Proven expertise in usage of MS Office Suite; CAD experience preferred
- Previous experience working with lab/industrial equipment required (if applicable)
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Substantial understanding of processes and equipment used in assigned work
- Good leadership skills and ability to influence change
- 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 inter-departmental teams and key contact representing the organization on contracts or projects
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
- 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
Senior Engineer, R&D - Irvine, United States - Edwards Lifesciences
Description
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.
At Edwards, innovation starts from the heart, and patients come first We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease and critical care. As a Senior Engineer in our THV R&D team, you'll work closely with Quality and Manufacturing to develop cutting-edge tools and technologies that address unmet clinical needs and improve patients' lives globally. Your primary focus will be developing the distal end of next-gen TAVR delivery systems, leveraging your strong problem-solving abilities, collaborative skills, and design and development expertise to work effectively with cross-functional and cross-site partners.
How you'll make an impact:
For California, the base pay range for this position is $103,000 to $146,000 (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 complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.