Senior Engineer, Manufacturing

Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.

How you will make an impact:

• Supporting Advanced Catheters by working in collaboration with Research & Development on New Product Development
• Leading the commercial line readiness for a new catheter that we are designing
• Identifying and ensuring implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) and employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards
• Leading the execution on all validations that are required by developing complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
• Analyzing and resolving complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
• Developing training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
• Leading and establishing project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
• Overseeing manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
• Other incidental duties assigned by Leadership

What you'll need (Required):

• Bachelor's Degree in an Engineering or Scientific field with 4 years of previous related experience required or
• Master's Degree or equivalent in an Engineering or Scientific field with 3 years of previous related experience required or
• Ph.D. or equivalent in an Engineering or Scientific field with industry experience or industry/education required
• Experience working in a manufacturing environment required
• Experience working in the medical device industry required
• Experience working in New Product Development or Research & Development required

What else we look for (Preferred):

• Experience working in catheter manufacturing
• Proven expertise in usage of SolidWorks
• Knowledge of material science
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Previous experience working with lab/industrial equipment
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Good leadership skills and ability to influence change
• Ability to manage competing priorities in a fast paced environment
• 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

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

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking