Prin R&D Engineer

Immediate opening for Prin R&D Engineer.  Be apart of an exciting R&D team responsible for ownership of taking a product from idea to commercialization.  This is a DIRECT HIRE opportunity for Edwards Lifesciences, global leader in products and technologies to treat advanced cardiovascular diseases. Headquartered in Irvine, CA, Edwards is the number one heart valve company in the world and employs over 5,500 people worldwide. 

This is a great leadership opportunity within the Heart Valve group.  Edwards is looking for a creative key player to lead a team of two or more engineers/technicians in the design and development of a delivery system for this novel medical device.  The delivery system group will be part of a larger concurrent engineering team developing medical devices in our Heart Valve business.

Key responsibilities include:

* Interface and manage internal and external vendors.

* Work closely with project team members, internal partners in the Regulatory, Quality, Manufacturing and other departments to deliver project objectives.

* Work closely with key clinical opinion leaders to understand the clinical requirements and translate them into the product testing.

Education/Experience include:

Must have experience developing delivery systems and other medical devices.  Experience designing and developing injection molded components is required. Experience in one or more of the following is preferred: tissue, heart valves, balloons, suture or suturing devices, injection molding, surgical instruments and cardiovascular physiology.

Must have a minimum of eight years experience, a master's degree (with a minimum of seven years experience, or a PhD (with a minimum of six years experience.)

Must possess a high level of understanding of interventional cardiology/cardiac surgery procedures as well as be able to evaluate device prototypes in animal/cadaver model in a cardiac catheterization laboratory / operating room setting in conjunction with partner physicians and other medical professionals.

Must be able to train physicians in the use of the new products as well as supporting early clinical evaluations.

Must be a hands-on engineer with strong mechanical design skills and highly proficient in the use of modeling software like pro-E and/or Solid Works to design and develop:
• Delivery Systems and other medical devices
• In-vitro test systems
• Simulators, including the design of equipment and fixtures
• Or any other bench test models required for device evaluation

A strong aptitude for mechanical design is required. Must demonstrate a high degree of creativity to generate or improve device concepts or designs based on physician and/or marketing input.

An understanding of product specifications as well as medical guidance and agency safety standards needed to effectively test devices is required.

Must possess effective communication skills with technical, non-technical and clinical personnel as well as internal and external customers. Candidate must have the ability to manage several parallel tasks at once. In addition, must be able to travel as needed, both domestic and abroad.

Must demonstrate a high degree of creativity, foresight, and sound judgment in planning, organizing, and guiding engineering programs and activities.