Principal Engineer, New Product Development

3 weeks ago

Irvine, United States Edwards Lifesciences Full time

Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives. 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. Perform other duties and responsibilities as assigned. What you’ll need (Required): 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. Travel 10% domestically or internationally. What else we look for (Preferred): 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 $115,000 to $163,000 (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 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. Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals 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 focus on helping patients regain and improve the quality of their life.

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