Senior Supplier Development Engineer
Company: Edwards Lifesciences Gruppe
Posted on: April 8, 2021
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account. Thank you for your patience. The Senior Supplier
Development Engineering will provide manufacturing engineering
support in the design and development of novel Hemodynamic and
Pressure Monitoring medical devices. 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. Essential job functions include:
- Working with multiple internal project teams to coordinate and
execute supplier development deliverables at external electronic,
plastic, cable, and sub-assembly component suppliers for Edwards
Critical Care 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
- 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
- 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 Critical Care
- Conducting supplier assessments to drive selection of robust
suppliers and development plans for those suppliers needing
- Supporting the generation and implementation of the Supplier
Development department's quality system procedures.
- Perform other duties and responsibilities as assigned.
- Bachelor's degree in engineering related field (e.g.
mechanical, electrical, or manufacturing)
- Four years of engineering experience in manufacturing
- Well-developed understanding and with experience in performing
medical device manufacturing process validations (IQ/OQ/PQ).
- Experience in medical device industry preferred.
- Equipment knowledge and process experience for PCBA, SMT,
injection molding, cable manufacturing, high volume product
assembly, and environmental controls (clean rooms and water
- Good engineering judgement and demonstrated analytical, quality
problem analysis, and resolution skills using Six Sigma
- 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),
- Domestic and international travel is required. Expected 25%
travel. E dwards is an Equal Opportunity/Affirmative Action
employer including protected Veterans and individuals with
disabilities. Posted 2 Days Ago Full time 020216 About Us 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.
Keywords: Edwards Lifesciences Gruppe, Irvine , Senior Supplier Development Engineer, Engineering , Irvine, California
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