Engineer II, Quality

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

You will make an impact by:

· Investigating moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.

· Optimizing moderately complex manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing, continuous process improvement, and improving product quality.

· Implementing strategic mistake proofing through code optimization to increase yield, decrease non-conformances, and increase capacity.

· Developing, updating, and maintaining technical content of risk management files.

· Developing training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.

· Assigning support tasks; giving instruction to technicians on conducting tests; training technicians and providing feedback; and may coordinate technician work.

What you’ll need (Required):

· Bachelor's Degree in Engineering or Scientific field with 2 years of related experience Required OR Master’s Degree in Engineering or Scientific field and an internship, senior project, or thesis in Engineering or Scientific field, including either industry or industry/education experience Required.

What else we look for (Preferred):

· Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills

· Basic understanding of statistical techniques

· Previous experience working with lab/industrial equipment

· 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 Quality systems

· 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

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.