Hiring company: Edwards Lifesciences
This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. The candidate will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use. The Engineer II, R&D Clinical Development applies knowledge of technical principles and Edwards systems/procedures to optimize product development.
Key Responsibilities including but not limited to:
- Create, test, and/or improve products by developing moderately 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 drawings/prototypes, etc. to establish/characterize product and/or process specifications.
- Create/update portions of design control documents including requirement specs and risk documents.
- Assign R&D 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.
- Domestic and international travel 25%.
- Perform other duties and responsibilities as assigned.
Required Qualifications:
- Bachelor's Degree in Engineering or Scientific field with 2 years of engineering experience.
- Medical device industry.
Preferred Qualifications:
- Master’s degree.
- CAD experience.
Additional Skills:
- Good computer skills in usage of MS Office Suite.
- 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 required (if applicable).
- 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.
- 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.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 or have a valid religious or medical exemption from being vaccinated.