Principal Manufacturing Engineer, NPD

Irvine, CA - USA

Monthly Salary: Not Disclosed

Posted on: 20 hours ago

Vacancies: 1 Vacancy

Job Summary

Innovation starts from the heart. At Edwards we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our New Product Development Engineering team you will work closely with our R&D and Quality teams to develop the latest tools and technologies to address significant unmet clinical needs that impact patients lives around the world.

Aortic stenosis impacts millions of people globally yet it often remains under-diagnosed and under-treated. Edwards groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How youll make an impact:

The THV New Product Development team is looking for a Principal Engineer to function as the Operations Integrator in support of the development of our next-generation THV sheath. This person will have the opportunity to drive the process design and characterization work on a strong cross-functional team and partner with the commercial site on process validations and commercialization activities. This position provides experience in the full development cycle from concept through to commercialization.

Optimize manufacturing processes by providing expert guidance to improve efficiency quality and scalability across operations leading New Product Development activities for the project
Lead design control activities for products and processes ensuring readiness for clinical trials and commercialization.
Develop and maintain comprehensive manufacturing documentation including drawings SOPs routers and pFMEAs across multiple release stages.
Oversee Participate in drawing review processes and ensure tolerance stack-up analysis to ensure compliance to meet quality standards.
Conduct fit testing of design parts and fixtures to align with pilot and commercial manufacturing expectations.
Create detailed training materials and work instructions to support production teams and enable smooth knowledge transfer.
Define processes implement robust process controls and evaluate new and existing standards for continuous improvement.
Influence specifications from an operations perspective (DFx tolerancing material selection automation) establish stability metrics and mitigate risks through Supply Chain Readiness Review (SCRR) and Manufacturing Readiness Review (MRR) processes. Leverage factory insights and SME knowledge to drive standardization and improvements.
Identify and implement design enhancements to optimize manufacturability and ease of production.
Utilize TOPP technology to design efficient production lines.
Lead build strategies prioritize activities and provide technical support for Quality System Testing (QST) pre-DV and DV phases.
Partner with Pilot R&D and Quality teams to resolve root causes in manufacturing processes prior to clinical and commercial builds commercialization.
Design and execute complex experiments and protocols to characterize and refine processes. Lead qualifications and validations (IQ OQ software) for manufacturing systems.
Mentor junior engineers through process development and execution.
Lead the design and development of manufacturing equipment and tooling for program-specific needs.
Analyze manufacturing and compliance issues (CAPA non-conformance audit observations) and provide technical support for process transfers.
Identify opportunities to redesign or improve equipment tools and fixtures across all design phases. Collaborate with R&D and manufacturing teams to implement improvements for pilot and commercial production.
Manage redesign opportunities and supplier-driven changes to ensure alignment with device design intent.
Apply engineering methods (e.g. LEAN principles basic statistics) to improve manufacturing processes and support stability metrics throughout design phases.
Follow project plans to ensure deliverables meet customer expectations using project management tools such as project plans and risk analysis.
Oversee manufacturing support tasks and supervise technicians and junior engineers.
Perform other incidental duties as assigned.

What youll need (Required):

Bachelors Degree in Engineering or Scientific field with 6 years experience including either industry or industry/education (or)
Masters Degree or equivalent in Engineering or Scientific field with 5 years experience including either industry or industry/education (or)
Ph.D. or equivalent in Engineering or Scientific field with 2 years experience including either industry or industry/education

What else we look for (Preferred):

Strong verbal/written communication and interpersonal skills
Strong project management skills
Basic understanding of statistical techniques required; Six Sigma Black Belt Certification preferred
Previous experience in a manufacturing support role preferred
Strong problem-solving organizational analytical and critical thinking skills
Process Validation experience required
Familiarity with Design for Manufacturability and LEAN is preferred
Capable of analyzing and solving complex problems through innovative thought and experience.
Ability to manage competing priorities in a fast-paced environment
Ability to work well independently as well as part of a team.
Good leadership skills and ability to influence change
Ability to interact professionally with all organizational levels

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 $121000 to $171000 (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:

Staff IC

How youll make an impact:

Optimize manufacturing processes by providing expert guidance to improve efficiency quality and scalability across operations leading New Product Development activities for the project
Lead design control activities for products and processes ensuring readiness for clinical trials and commercialization.
Develop and maintain comprehensive manufacturing documentation including drawings SOPs routers and pFMEAs across multiple release stages.
Oversee Participate in drawing review processes and ensure tolerance stack-up analysis to ensure compliance to meet quality standards.
Conduct fit testing of design parts and fixtures to align with pilot and commercial manufacturing expectations.
Create detailed training materials and work instructions to support production teams and enable smooth knowledge transfer.
Define processes implement robust process controls and evaluate new and existing standards for continuous improvement.
Influence specifications from an operations perspective (DFx tolerancing material selection automation) establish stability metrics and mitigate risks through Supply Chain Readiness Review (SCRR) and Manufacturing Readiness Review (MRR) processes. Leverage factory insights and SME knowledge to drive standardization and improvements.
Identify and implement design enhancements to optimize manufacturability and ease of production.
Utilize TOPP technology to design efficient production lines.
Lead build strategies prioritize activities and provide technical support for Quality System Testing (QST) pre-DV and DV phases.
Partner with Pilot R&D and Quality teams to resolve root causes in manufacturing processes prior to clinical and commercial builds commercialization.
Design and execute complex experiments and protocols to characterize and refine processes. Lead qualifications and validations (IQ OQ software) for manufacturing systems.
Mentor junior engineers through process development and execution.
Lead the design and development of manufacturing equipment and tooling for program-specific needs.
Analyze manufacturing and compliance issues (CAPA non-conformance audit observations) and provide technical support for process transfers.
Identify opportunities to redesign or improve equipment tools and fixtures across all design phases. Collaborate with R&D and manufacturing teams to implement improvements for pilot and commercial production.
Manage redesign opportunities and supplier-driven changes to ensure alignment with device design intent.
Apply engineering methods (e.g. LEAN principles basic statistics) to improve manufacturing processes and support stability metrics throughout design phases.
Follow project plans to ensure deliverables meet customer expectations using project management tools such as project plans and risk analysis.
Oversee manufacturing support tasks and supervise technicians and junior engineers.
Perform other incidental duties as assigned.

What youll need (Required):

Bachelors Degree in Engineering or Scientific field with 6 years experience including either industry or industry/education (or)
Masters Degree or equivalent in Engineering or Scientific field with 5 years experience including either industry or industry/education (or)
Ph.D. or equivalent in Engineering or Scientific field with 2 years experience including either industry or industry/education

What else we look for (Preferred):

Strong verbal/written communication and interpersonal skills
Strong project management skills
Basic understanding of statistical techniques required; Six Sigma Black Belt Certification preferred
Previous experience in a manufacturing support role preferred
Strong problem-solving organizational analytical and critical thinking skills
Process Validation experience required
Familiarity with Design for Manufacturability and LEAN is preferred
Capable of analyzing and solving complex problems through innovative thought and experience.
Ability to manage competing priorities in a fast-paced environment
Ability to work well independently as well as part of a team.
Good leadership skills and ability to influence change
Ability to interact professionally with all organizational levels

For California (CA) the base pay range for this position is $121000 to $171000 (highly experienced).

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

COVID Vaccination Requirement

Required Experience:

Staff IC

Key Skills

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

Apply Now

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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