Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring, with more than five decades of experience in partnering with clinicians to develop life-saving innovations. Headquartered in Irvine , Calif. , Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company has more than 6,200 employees worldwide.
For us, helping patients is not a slogan – it's our life’s 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 help ensure that patients regain and even improve their quality of life.
Principal Engineer Critical Care R&D
Opportunity Snapshot:
High level and hands-on R&D engineering position that leverages medical device development / quality / manufacturing experience in new product and process development.
This position is in the R&D department within Edwards Critical Care business unit which is focused on products designed for monitoring of hemodynamic parameters.
Our Requirements:
*Multi-level position: Position title and level posted is preferred. However, we will also consider hiring at the Staff Engineer level.
A minimum of five years work experience is required for the Staff Engineer level. A minimum of seven years experience is required for the Principal Engineer level. Strong preference for experience in the medical device or other highly regulated industry with emphasis on Medical Sensors, Catheters(electrophysiology), or instrumentation/monitors (analog & digital electronics).
Preferred experience to include any of the following:
• Previous systems engineering experience using disposable catheters / sensors and electronic patient monitors
• Experience as the lead R&D engineer on a medical device product development program
• Experience in product design verification and validation via test equipment development and equipment validation (IQ/OQ/PQ) within an FDA regulated or other regulated industry (i.e. bio-tech/pharma, aerospace, food/beverage)
• Clinical trial and/or animal trial experience
• Demonstrated experience in application of lean manufacturing principles.
A bachelor's degree in Mechanical Engineering or other engineering discipline is required.
Additional Skills:
• Proficient in technical writing of protocols and reports
• Proven capability in writing clear and detailed testing and product assembly procedures
• Impeccable documentation skills and adherence to design control procedures and GLP
• Comfortable in a dynamic working environment with a high amount of change
• Six sigma green belt certification desired.
• Demonstrated ability in using statistical experimental design and analysis techniques (i.e. Taguchi Design of Experiments)
• Demonstrated proficiency in mechanical design, design for Manufacturability (DFM), specification development, product verification and validation testing, medical device new product development and rapid prototyping
• Familiarity with LabView, Matlab, and/or Pro-E
• Must be a highly motivated self-starter who is able to achieve results with minimal direction
• Requires a high-energy individual who has excellent teamwork, partnering, and negotiation skills
• Must be proactive and creative in achieving goals
• Excellent verbal and written communication skills, project management skills, internal drive, detail orientation and analytical/problem solving skills are required for success in this position
How to Apply:
At Edwards Lifesciences, we want you to have as much information as possible before making an important career decision. To find out more about this role and the opportunity it offers, please visit our website:
www.edwards.com
OR
To apply directly to this position, please click the link below or cut and paste it into your browser:
http://www.edwards.com/Careers/reqfinder?urlvariablestring=3492
***Note to Agencies and Recruiters: Edwards Lifesciences is not accepting referrals from Agencies or Recruiters.
Resumes received by Edwards Lifesciences from search firms and/or individual recruiters are considered unsolicited.
Agencies and Recruiters: Refrain from contacting managers directly, to solicit job orders. Contact the Edwards Lifesciences Human Resources Department via e-mail at EW_Talent_Acquisition@edwards.com or call our dedicated Talent Acquisition hotline at 949-250-3422. Thank you.
