Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you’ll make an impact: 

• Drive NPD manufacturing engineering activities for Edwards' SURGICAL 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 SURGICAL 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.   

• Operations technical leader for 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. 

• Leads development of pFMEA. 

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

• Develop 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. 

• Travel 10% domestically or internationally.

• Perform other duties and responsibilities as assigned.      

What you’ll need:  

• Bachelor's Degree in Engineering or Scientific field with 6 years of manufacturing, NPD, and/or NPI engineering experience. 

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

What else we look for:  

• 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. 

• Lean and/or Six Sigma certifications. 

• Proven track record in 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. 

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

• Expertise in usage of 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 $118,000 to $167,000 (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.