Orange County Metro Area, CA
Santa Ana, CA
Job Description & Qualifications
The Senior Supplier Development Engineering will provide manufacturing engineering support in the design and development of novel Transcatheter Mitral and Tricuspid therapy devices (TMTT). This individual will conduct operations engineering activities at key suppliers from initial product development phase through commercial product launch.
Among these activities are: applying Design for Manufacturability (DFM) concepts into component designs, collaborating with suppliers in the development of highly capable manufacturing processes to meet new product demands, performing process failure mode analysis, conducting supplier process validations and others related to design-transfer-to-manufacturing at suppliers.
This is a dynamic, hands-on and supplier-focused role that will work in close partnership with R&D, Supplier Quality, Global Sourcing and Edwards Manufacturing Plants.
Working with multiple internal project teams to coordinate and execute supplier development deliverables at external plastic, metal, and sub-assembly component suppliers for Edwards TMTT products.
Assisting suppliers to ensure that selection, development, and validation of manufacturing processes, equipment, and tooling are performed to the meet Edwards procedures, ISO 13485 and FDA requirements.
Being the primary contact for designated suppliers and ensuring that all phases of product/process development conform to required quality standards while meeting program timing/key milestones for production launch.
Developing and writing technical reports/summaries, and validation/verification documents. Properly documenting activities in accordance with best engineering practices, company procedures, and regulatory requirements.
Resolving supplier component-related problems, including yield issues and failure analyses.
Providing ongoing quality monitoring and interface with external suppliers on manufacturing line issues to ensure highest quality product is maintained.
Training and educating suppliers on industry best practices and requirements to develop and improve their ability to meet medical device manufacturing industry expectations.
Facilitating and managing component level qualification testing that leads to the approval of components for use in TMTT products.
Conducting supplier assessments to drive selection of robust suppliers and development plans for those suppliers needing performance improvement.
Supporting the generation and implementation of the Supplier Development department s quality system procedures such as initiation of SQRs, purchased part DMRs, FAI reports
Perform other duties and responsibilities as assigned.
Four years of engineering experience in medical device manufacturing preferred.
Well-developed understanding and with experience in performing medical device manufacturing process validations (IQ/OQ/PQ).
Equipment knowledge and process experience for injection molding, catheter manufacturing, high volume product assembly, and environmental controls (clean rooms and water processing) preferred
Good engineering judgement and demonstrated analytical, quality problem analysis, and resolution skills using Six Sigma methodologies.
Strategic planning and critical thinking skills to be able to plan, organize, and manage multiple priorities.
Ability to read and interpret engineering drawings for the purpose of understanding product design and identifying to critical to quality features.
Strong understanding of statistical techniques (Gage R&R, SPC, Process Capability Analysis, ANOVA, etc.) is required. Lean Six Sigma certification is preferred.
Ability to work well both independently and as a member of a team is essential.
Excellent documentation and communication skills and interpersonal/intercultural relationship skills including negotiating and relationship management skills.
Knowledgeable in the use of Software: MS Office Package, Minitab (or equivalent statistical analysis software)
Ability to travel both domestic and international is required.
Expected 25%-30% travel
Bachelor's degree in an engineering or scientific field is required.