Senior Manufacturing Engineer, New Product Development

Innovation starts from the heart. At Edwards we put patients first. We invest a significant proportion of our revenue in research and development to create 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 partners to develop the latest tools and technologies that address significant unmet clinical needs for patients around the world.

Were dedicated to pioneering next-generation innovations for patients with aortic regurgitation (AR). Our Transcatheter Heart Valve (THV) business unit brings together Clinical Affairs Engineering and Research professionals to design and develop minimally invasive therapies that impact patient outcomes and quality of life. Were working together to transform cardiovascular care and device development to address unmet patient needs in structural heart disease. Join us and be part of our inspiring journey.

How youll make an impact

• Apply technical principles and Edwards systems/procedures to optimize manufacturing processes.

• Support and drive complex design control activities related to manufacturing products and processes.

• Develop manufacturing documentation (e.g. drawings SOPs routers pFMEAs) at various release levels ensuring accuracy of drawing reviews and compliance with tolerance stack-ups.

• Create advanced training and documentation materials (e.g. work instructions) to enable seamless transfer of knowledge for project and manufacturing processes.

• Execute and create process definitions and process controls while evaluating new and existing standards.

• Drive specifications from an operations perspective (e.g. DFx tolerancing material selection automation) establish stability metrics and mitigate risks through SCRR and MRR.

• Leverage Voice of the Factory and SME knowledge to drive improvements and standardization.

• Lead build strategy prioritization and technical support for QST pre-DV and DV phases serving as a key partner to Pilot during root-cause investigations related to manufacturing processes prior to commercialization.

• Develop complex experiments and testsincluding writing and executing protocolsto characterize and advance processes.

• Execute IQ/OQ/software qualifications and validations and mentor junior engineers through these activities.

• Collaborate with cross-functional teams on the development of manufacturing equipment engineering solutions and tooling design (program-specific).

• Lead analysis of manufacturing and compliance issues (e.g. CAPA nonconformance audit observations) and provide technical support during process transfer.

• Identify opportunities to design or re-design equipment tools fixtures and related components to improve manufacturing processes.

• Improve manufacturing processes using engineering methods (e.g. LEAN methods basic statistics) to support continuous improvement activities.

• Follow project plans and ensure deliverables meet customer expectations using project management tools (e.g. project plans risk analyses).

• Perform other incidental duties as assigned by leadership.

What youll need (Required):

• Bachelors degree in an Engineering or Scientific field and 4 years of experience in industry or a combination of industry and education; or

• Masters degree in an Engineering or Scientific field and 3 years of experience in industry or a combination of industry and education; or

• Ph.D. in an Engineering or Scientific field with relevant industry or industry/education experience.

What else we look for (Preferred):

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.