Senior Engineer, R&D - Irvine, United States - Edwards

Description

Edwards Lifesciences Careers

**Senior Engineer, R&D - Delivery Systems**

**type** Full time

**Location** USA, California, Irvine

**Job reference** Req-14066

**Posted for** 16 Days

**Were looking for engineers with *HEART*.** At Edwards Transcatheter Mitral and Tricuspid Therapies (TMTT), we are guided by our vision to lead and transform treatment for patients with mitral and tricuspid heart valve disease.

True to our patients-first focus, TMTTs engineers puts their whole hearts into meeting the needs and improving the lives of this largely underserved patient population. The anatomies and clinical challenges that exist among patients with mitral and tricuspid valve disease are varied and complex, and we are committed to the development of a portfolio of therapies that transforms treatment and provides world-class outcomes.

So, if youre an exceptional Engineering professional with significant experience and a heart for solving complex challenges, join our team and help us improve patients lives through the development of transcatheter mitral and tricuspid therapies from the ground up.

As an integral part of the R&D team, the **Senior Engineer** will play a pivotal role in an early-stage design and development program through critical commercialization activities for the next-gen PASCAL delivery system.

**Essential Job Functions**

Design and develop of a commercial-ready implant delivery system including catheters, handles and accessories

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 complex design control documents including requirement specs, and risk documentation

Develop and execute engineering project plans

Coordinate with critical suppliers to identify, evaluate, manage, and provide guidance - , 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

**Required Education and Experience:**

-Bachelor's Degree + 4 years of experience OR

Master's Degree + 3 years of experience

-Experience in the medical device industry

-Experience with catheter and delivery system development

-CAD experience required

**Preferred Experience:**

-Experience with the full R&D product development lifecycle is highly preferred

-Experience with design and development of nitinol is a plus

-Experience using six sigma blackbelt tools such as DOE, multi-vari analysis, and GR&R are highly preferred

**Additional Skills:**

Proven expertise in usage of MS Office Suite

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 required (if applicable)

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 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

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.

**About Edwards Lifesciences**

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the worlds leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - its our lifes work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

**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 or have a valid religious or medical exemption from being vaccinated. 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.

For United States Applicants Only:

EEO is the Law for more information regarding Equal Employment Opportunity

**Disability accommodation for employment applicants**

Reasonable accommodation will be provided for qualified individuals with disabilities and disabled veterans in job application procedures. If you have any difficulty using our online system and need an accommodation due to a disability, you may contact us at for assistance. Please include a description of your requested accommodation, your name and contact information.

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