2nd Shift Engineer II, Manufacturing

2 weeks ago

Irvine, United States Edwards Lifesciences Full time

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.

2nd Shift hours are: Monday to Friday from 1:00 p.m. to 10:00 p.m.

How you will make an impact:

Optimizing manufacturing processes, 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 processes; 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 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. Coordinating with First Shift Engineering/Operations/Quality team members as needed.

What you’ll need (Required):

Bachelor's Degree in Engineering or Scientific field with 2 years of industry related experience OR a Master’s Degree in Engineering or Scientific field with internship, senior projects, or thesis experience Required.
 

What else we look for (Preferred):

Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable) Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills Basic understanding of statistical techniques Previous experience working with lab/industrial equipment required (if applicable) Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering Solid problem-solving, organizational, analytical 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 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 requirements.

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