Senior Quality Engineer

2 weeks ago

Irvine, United States Edwards Lifesciences Gruppe Full time

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Senior Quality Engineer – Pilot (THV Programs)

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locations

USA - California – Irvine

time type

Full time

posted on

Posted 2 Days Ago

job requisition id

Req-33208

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. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: Investigate 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.

Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.

Develop, update, and maintain technical content of risk management files

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

Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.

Train, coach, and guide lower level employees on routine procedures

Other incidental duties assigned by Leadership

What you’ll need (Required): Bachelor's Degree in in Engineering or related field, 4 years experience related industry experience Required or

Master's Degree or equivalent in in Engineering or related field, 3 years experience related industry or industry/education experience Required or

Ph.D. or equivalent in in Engineering or related field, 0 years experience Required

What else we look for (Preferred): Proven expertise in usage of MS Office Suite; CAD experience preferred

Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills

Working knowledge and understanding of statistical techniques

Previous experience working with lab/industrial equipment required

Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering

Strong problem-solving, organizational, analytical and critical thinking skills

Substantial understanding of processes and equipment used in assigned work

Good leadership skills and ability to influence change

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 inter-departmental teams and key contact representing the organization on contracts or projects

Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

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

$103,000 to $146,000 (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. E dwards 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.

About Us

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

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