Engineer II, New Product Development, TMTT in Irvine, California

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

This is an exciting opportunity to join the Transcatheter Mitral Tricuspid Therapies (TMTT) New Product Development (NPD) organization. The Engineer II will have high collaboration between R&D, Pilot and commercial manufacturing, contribute to from Early Human Use to commercialization of new product in the TMTT business unit, and the development of new or optimized manufacturing processes for TMTT devices focused on patient needs.

How you’ll make an impact:

• Drive NPD manufacturing engineering activities for Edwards’ TMTT portfolio of Class III implantable devices and/or treatments for structural heart disease. Scope of programs could range from Early Human Use to commercialization of new products in the TMTT space.

• Ensure that design and manufacturing processes are characterized, robust, scalable utilizing appropriate technologies, are capable and compliant with regulatory requirements. Ensure processes are validated for design control by leveraging engineering best practices from LEAN Six Sigma, DFx, including design and process 3P.

• Partner with technical engineers on new products in the PDP process and its main interface between R&D, quality, pilot, supplier development, and commercial manufacturing.

• Provide relevant inputs to the development team on device manufacturability. As required, generate data or information through DOE, characterization studies, stack-up analyses, etc.

• Support operational transitions through development, clinical, and commercialization phases and ensure completion of Design Transfer deliverables.

• Responsible for the development of applicable Process Development (IQ/OQ/PQ) protocols and provide support for execution of validation plans and reports.

• Manage pilot production builds, planning, tracking and execution.

• Drive the development and manage the execution of complex experiments and tests (including writing an executing protocols) on new or existing product lines to qualify and validate manufacturing processes, analyze results, make recommendations, and develop reports.

• Responsible for characterization and validation activities, including CTQ flow-down and identification of critical control points within manufacturing.

• Act as the liaison between Contract Manufacturing Organization (CMO), and Edwards to co-ordinate manufacturing activities as directed by the NPI lead.

• Support manufacturing risk assessment and identify mitigations.

• Responsible for part/drawing release, and accuracy of the Bill of Materials (BOM).

• Review engineering product specifications, CAD data/drawing, as part of design review process to ensure they meet industry and manufacturing standards and practices.

• Perform other duties and responsibilities as assigned.

What you’ll need (Required):

• Bachelor’s Degree in Engineering or Scientific field with 2 years of manufacturing, NPD, and/or NPI engineering experience.

• Travel 10% domestically or internationally.

What else we look for (Preferred):

• Product development experience, with a working knowledge of manufacturing phase gate requirements.

• Medical device manufacturing experience in heart valves, stents, tissue, catheters, delivery systems and/or interventional access devices.

• Understanding of engineering principles including GD&T, tolerance stack-up analysis, CTQ/CCP.

• Design transfers to operations and process, equipment validation experience.

• Understanding of injection molding, polymers, and commonly used materials in the medical device space, such as nitinol, implantable devices, and metals processing.

• Design for manufacturability, design and process excellence methodologies including Six Sigma, LEAN experience, cGMP, EH&S guidelines, supplier development engineering and process validation.

• Proficient in MS Office Suite.

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 $83,000 to $117,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.