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 sustaining team supporting the 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:
- Optimizing manufacturing equipment/system operation, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills.
- Developing moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing equipment/system operation; analyzing results, making recommendations, and developing reports.
- Analyzing and resolving moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
- Developing training and documentation materials (e.g., work instructions) for equipment maintenance/production to enable the seamless knowledge transfer of project and manufacturing processes.
- 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; giving instruction to technicians on conducting tests; training technicians and providing feedback; and coordinating technician work.
What you’ll need (Required):
- A Bachelor's degree in Engineering or Scientific field with 2 years of previously related industry experience OR Master’s degree in Engineering or Scientific field Required.
What else we look for (Preferred):
- Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred
- Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
- Basic understanding of RCM, Failure Modes, MRO, PM programs tracked by MTBF, MTTR, and statistical techniques preferred
- Previous experience working with industrial equipment (AHUs, Water System, Chiller, Humidifiers, Boilers, Air compressors, Autoclaves, Oven, Laser, Printers, etc.) preferred
- Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Solid problem-solving, organizational, analytical, root cause analysis, and critical thinking skills
- Solid understanding of processes and equipment used in assigned work
- Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
- Knowledge of applicable FDA regulations for medical device industry
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast-paced environment
- Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
- Ability to build productive internal/external working relationships
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 $83,000 to $117,000 (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.