Engineer Ii, R&D, Tmtt

The time is now to join TMTT (Transcatheter Mitral and Tricuspid Therapies) and shape the therapies that will transform treatment. Do not miss your chance to be part of a dynamic, challenging, and rewarding environment that offers potential for growth and professional advancement for the right candidate. This position will allow someone to get in on the ground floor and have a meaningful and direct impact on the development activities for a new cutting-edge delivery system and accessories. Join a highly motivated team that thrives in a fast-paced environment.

Key Responsibilities:

• Other duties assigned by Leadership.
• Generate test protocols, reports and supporting documentation for design verification.
• Provide R&D engineering support and drive the development activities to launch next gen accessories package
• Partner with project team members, internal partners, and suppliers to deliver project objectives.
• Develop and qualify test methods and procedures.
• Subject matter expert responsible for successfully transferring a next generation sheath between two R&D sites for validation with the next generation delivery system
• Document design requirements, drawings and processes in conformance with Edwards design control procedures
• Solve design, process and testing problems at the component through system levels.

Basic Qualifications:

• Bachelor’s degree in engineering or Scientific field & 2+ years of experience in various phases of R&D -or- NPD is required -OR-
• Master's Degree or equivalent in Engineering or Scientific field & co-op or internship experience in various phases of R&D -or- NPD is required

Preferred Qualifications:

• Strong mechanical aptitude
• Direct experience in class III medical device or other highly regulated industry is strongly preferred
• Human factors engineering experience
• Design for manufacturing experience (DFM)
• Proficiency in Solidworks
• Sheath/catheter materials and construction a strong plus

Additional Skills:

• High energy self-starter
• Strict attention to detail
• Effective communication, listening, and diagnostic skills, verbal and written, are necessary.
• Ability to interact professionally with all organizational levels.
• Basic understanding of statistical techniques
• Good computer skills in usage of MS Office Suite
• Good understanding of processes and equipment used in assigned work.
• Must be able to work in a team environment, including immediate supervisor and other team members in the section or group.
• Looking for an agile engineer who thrives in a fast-paced team to drive and deliver results, while managing competing priorities.
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.
• Strong background and understanding of design control and risk management.
• Good problem-solving, organizational, analytical and critical thinking skills
• Proficiency in technical writing of protocols, reports, and technical summaries is required.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $81,000 to $114,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

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.