Principal Engineer, New Product Development
Edwards Lifesciences
- Irvine, CA
- $115,000-163,000 per year
- Permanent
- Full-time
- 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.
- 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.
- 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.