Senior Engineer, Manufacturing

Irvine, CA - USA

Monthly Salary: Not Disclosed

Posted on: 2 hours ago

Vacancies: 1 Vacancy

Job Summary

Innovation starts from the heart. Our Advanced Innovation & Technology (AI&T) teams harness the imagination courage and resourcefulness to think beyond whats currently possible and create solutions for patients many years into the future. If youre an early-stage innovator then Edwards AI&T team is the place for you to take the next steps in your career. Well give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.

The Senior Engineer is responsible for providing technical ownership to successfully develop qualify and transfer manufacturing technologies to commercialize new products in the Advanced Innovation Technology (AI & T) Business Unit. This individual will also advance the objectives of the Global Supply Chain (GSC) by supporting supply chain development and associated engineering activities from early product development through product launch while ensuring that manufacturing processes are developed that fully meet the operational needs for commercial success. The Senior Engineer will work collaboratively with R&D supplier development quality Pilot ops etc. to support product development and deliver on the goals and objectives of the AI&T BU.

How youll make an impact:

Apply knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.
Lead process development and validation for device releases using DMAIC methods.
Design and execute experiments to validate processes analyze data and report findings.
Identify and implement manufacturing improvements using Six Sigma LEAN and technical design approaches ensuring equipment meets standards.
Collaborate with cross-functional teamsincluding Pilot Ops GSC R&D PMO Design Assurance and Regulatoryto align objectives and fulfill BU commitments for product builds evaluations and assigned downstream needs.
Manage the design and development of manufacturing tools fixtures and equipment that meet Edwards standards for quality reliability mistake-proofing EH&S and ergonomics.
Drive build strategy prioritization and technical support for QST preDV and DV phases serving as a key partner to Pilot Ops on root-cause investigations for manufacturing processes.
Create training and documentation to support smooth process transfer to production.
Supervise manufacturing tasks direct and train technicians and manage their workflow.

What youll need (Required):

Bachelors Degree in Engineering or Scientific field with 4 years experience including either industry or industry/education (or)
Masters Degree or equivalent in Engineering or Scientific field with 3 years experience including either industry or industry/education (or)
Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education

What else we look for (Preferred):

Proven expertise using the MS Office Suite including MS Project; CAD experience preferred (if applicable).
Strong documentation communication (written and verbal) and interpersonal relationship skills including consultative and relationshipmanagement capabilities.
Basic understanding of statistical techniques.
Previous experience working with lab or industrial equipment (if applicable).
Substantial understanding and knowledge of principles theories and concepts relevant to Engineering.
Strong problemsolving organizational analytical and criticalthinking skills.
Substantial understanding of processes and equipment used in assigned work.
Good leadership skills and the ability to influence change.
Knowledge of and adherence to Edwards Environmental Health & Safety and Quality guidelines as they relate to cleanroom medical device manufacturing.
Knowledge of applicable FDA regulations for the medical device industry.
Strict attention to detail.
Ability to interact professionally with all organizational levels.
Ability to manage competing priorities in a fastpaced environment.
Ability to work effectively in a team environment including interdepartmental teams and serve as a key contact representing the organization on contracts or projects.
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
Adherence to all company rules and requirements (e.g. pandemic protocols Environmental Health & Safety rules) and taking adequate control measures to prevent injuries and environmental harm within ones span of influence/control.

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 (CA) the base pay range for this position is $108000 to $153000 (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 protecting our vulnerable patients and the healthcare providers who are treating them. As such all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role as a condition of employment you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.

Required Experience:

Senior IC

How youll make an impact:

Apply knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.
Lead process development and validation for device releases using DMAIC methods.
Design and execute experiments to validate processes analyze data and report findings.
Identify and implement manufacturing improvements using Six Sigma LEAN and technical design approaches ensuring equipment meets standards.
Collaborate with cross-functional teamsincluding Pilot Ops GSC R&D PMO Design Assurance and Regulatoryto align objectives and fulfill BU commitments for product builds evaluations and assigned downstream needs.
Manage the design and development of manufacturing tools fixtures and equipment that meet Edwards standards for quality reliability mistake-proofing EH&S and ergonomics.
Drive build strategy prioritization and technical support for QST preDV and DV phases serving as a key partner to Pilot Ops on root-cause investigations for manufacturing processes.
Create training and documentation to support smooth process transfer to production.
Supervise manufacturing tasks direct and train technicians and manage their workflow.

What youll need (Required):

Bachelors Degree in Engineering or Scientific field with 4 years experience including either industry or industry/education (or)
Masters Degree or equivalent in Engineering or Scientific field with 3 years experience including either industry or industry/education (or)
Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education

What else we look for (Preferred):

Proven expertise using the MS Office Suite including MS Project; CAD experience preferred (if applicable).
Strong documentation communication (written and verbal) and interpersonal relationship skills including consultative and relationshipmanagement capabilities.
Basic understanding of statistical techniques.
Previous experience working with lab or industrial equipment (if applicable).
Substantial understanding and knowledge of principles theories and concepts relevant to Engineering.
Strong problemsolving organizational analytical and criticalthinking skills.
Substantial understanding of processes and equipment used in assigned work.
Good leadership skills and the ability to influence change.
Knowledge of and adherence to Edwards Environmental Health & Safety and Quality guidelines as they relate to cleanroom medical device manufacturing.
Knowledge of applicable FDA regulations for the medical device industry.
Strict attention to detail.
Ability to interact professionally with all organizational levels.
Ability to manage competing priorities in a fastpaced environment.
Ability to work effectively in a team environment including interdepartmental teams and serve as a key contact representing the organization on contracts or projects.
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
Adherence to all company rules and requirements (e.g. pandemic protocols Environmental Health & Safety rules) and taking adequate control measures to prevent injuries and environmental harm within ones span of influence/control.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Required Experience:

Senior IC

Key Skills

Lean Manufacturing
Six Sigma
CNC Programming
Lean
Machining
Tooling
CAD
CNC
Assembly Experience
SolidWorks
Kaizen
Manufacturing

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About Company

Edwards Lifesciences

Edwards Lifesciences (NYSE: EW), is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakehol ... View more

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