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account. Thank you for your patience. Senior Manufacturing
Engineer, GSC Pilot Implantables USA - California – Irvine
The Senior Manufacturing Engineering role is a great opportunity
to support Edwards Lifesciences’ dynamic and rapidly growing Global
Supply Chain (GSC) pilot manufacturing team. The vision of the
organization is to enable Edwards to achieve rapid product
development cycles coupled with exceptional product reliability,
efficient cost, and real-time product transfer to the global plant
network. As a Sr. Manufacturing Engineer, you will be providing
engineering support during Design Verification & Clinical Builds by
participating in the Material Review Board (MRB), lead and perform
Non-conformance Report (NCR). Working closely with New Product
Development (NPD) team, you will represent Pilot Manufacturing
Engineering by providing input on manufacturing processes and
Device Master Records creation. Lead and support Pilot initiatives
to implement manufacturing best practices and production transfer
Essential job functions:
I dentify and ensure implementation of opportunities to
optimize/improve manufacturing processes including using
engineering methods (e.g., SIX Sigma and LEAN methods) employing
technical design skills to re-design/design of and ensure
equipment, tools, fixtures, etc are up to standards.
Analyze and resolve complex Manufacturing and Compliance issues
(e.g., CAPA, non-conformances, audit observations).
Develop complex experiments and tests (including writing and
executing protocols) to qualify and validate manufacturing
processes (IQ/OQ/PQ/SWV/TMV); analyze results, make
recommendations, and develop reports.
Develop training and documentation materials (e.g., work
instructions) for production to enable the seamless knowledge
transfer of project and manufacturing processes.
Lead and establish project plans to ensure deliverables are
completed to customer’s expectations, using project management
tools (e.g., Project Plan, Risk Analysis, etc.).
Oversee manufacturing support tasks; give instruction to
technicians on conducting tests; train technicians and provide
feedback; and coordinate technician work.
Perform other duties and responsibilities as assigned.
Bachelors degree in engineering or scientific with 4 years of
Advance degree is preferred.
Class II and Class III medical device manufacturing experience
Lean Six Sigma certification is preferred.
Extensive knowledge and understanding of principles, theories,
and concepts relevant to Engineering as well as the production
development process (PDP).
Advanced problem-solving, organizational, analytical and
critical thinking skills.
Effective communication and project management skills are
Strong analytical, problem solving, and technical writing
Ability to work well independently based on minimal
Strong interpersonal and intercultural skills are required.
E dwards is an Equal Opportunity/Affirmative Action employer
including protected Veterans and individuals with disabilities.
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 13,000 individuals
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.