Senior Manufacturing Engineer, NPD, AI&T

Innovation starts from the heart. Our AdvancedInnovation &Technology (AI&T) teams harness the imagination courage and resourcefulness to think beyondwhatscurrently possible and create solutions for patients many years into the future. Ifyourean early-stage innovator thenEdwardsAI&T team is the place for you to take the next steps in your you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.

Imagine how your ideas andexpertisecan change a patients life. Our GlobalOperations &Qualityteam plays a central part in ensuring our products are delivered to patients with cardiovascular cross-functionally with manufacturing operations and sales teams delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning labeling warehouse management material handling or any of our other supply chain opportunities you will be making a meaningful contribution to our team and to patients all over the world.

How you will make an impact:

• Drive optimization and redesign of manufacturing processesby applying advanced engineering methodologies (e.g. Six Sigma Lean) to improve efficiency quality and scalability; ensure equipment tooling and fixtures meet performance and compliance standards

• Lead complex process development qualification and validation activitiesby designing and executing experiments and protocols; analyze data generate insights and deliver recommendations and technical reports

• Resolve complex manufacturing and compliance issuesincluding CAPAs non-conformances and audit observations ensuring timely root cause identification and sustainable corrective actions

• Own and execute project plans for NPD initiativesby defining deliverables managing risks and ensuring alignment to customer expectations using structured project management tools and methodologies

• Provide technical leadership on the production floorby overseeing manufacturing support activities guiding and developing technicians and ensuring effective execution of testing and process controls

• Enable knowledge transfer and process adoptionby developing clear standardized documentation (e.g. work instructions training materials) to support production readiness and operational consistency

• Perform other incidental duties as assigned by leadership

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

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

What else we look for (Preferred):

• Experience with Edwards systems and training including Windchill (PLM) strongly preferred with demonstrated ability to navigate and leverage these tools to support product development and documentation processes

• Working knowledge of CAD and engineering design tools (as applicable) along with proficiency in MS Office Suite (including MS Project)to support technical analysis planning and execution

• Strong understanding of engineering principles manufacturing processes and equipmentrelevant to assigned areas with the ability to apply this knowledge to solve complex problems

• Knowledge of applicable FDA regulations within the medical device industry ensuring alignment with compliance quality and audit expectations

• Experience working with lab and/or industrial equipment (as applicable)to support testing validation and manufacturing activities

• Foundational understanding of statistical techniquesto support data-driven decision making and process validation

• Demonstrated problem-solving analytical and critical thinking skills with the ability to diagnose issues and recommend effective solutions

• Strong documentation and communication skills (written and verbal) with the ability to clearly convey technical information and engage effectively across stakeholders

• Proven leadership and influencing skills with the ability to drive change and collaborate across cross-functional teams

• Strong organizational skills and ability to manage competing prioritiesin a fast-paced NPD and manufacturing environment

• Demonstrated attention to detailto ensure accuracy quality and compliance in all outputs

• Ability to build effective working relationships and interact professionally across all levels of the organization including serving as a key contact on cross-functional projects

• Ability to work effectively in team environments including interdepartmental collaboration and project-based work

• Adhere to all company rules and requirements (e.g. pandemic protocols Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their 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 the base pay range for this position is $108000 - $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.