Quality Engineer II NPD
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Job Location:
Irvine, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Imagine how your ideas and expertise can change a patients 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. Youll bring your passion for problem solving and partner with various teams to influence decision-making for a products 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. Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
You will apply your knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards systems/procedures to optimize product development internal and external device manufacturing and device distribution.
How you will make an impact:
Support design assurance and development activities (i.e. requirement development risk assessment engineering study feasibility testing drawing review etc.) for New Product Development program
Participate in test method development/validation activities for New Product Development programs.
Collaborate with the R&D and Sustaining organizations to help facilitate the successful execution of the NPD process and launching of robust products
Develop experiments and tests (including writing and executing protocols) to create validate and improve products and manufacturing processes/methods based on engineering principles; analyze results make recommendations and develop reports.
Investigate complaints from clinical cases which may include:
- Reviewing customer experience reports to determine potential device contribution
- Hands-on evaluation of product returned from the field
- Assess against risk management documentation updating as necessary
Support product release processes including disposition of product and material quality control.
Develop update and maintain technical content of risk management files (e.g. FMEAs Quality Control Plans)..
Develop training and documentation materials for production (e.g. work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
Implement and approve compliant change control.
Support to external and internal audits.
Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
Other incidental duties assigned by Leadership
What youll need (Required):
Bachelors Degree in Engineering or Scientific field 2 years experience related work experience OR
Masters Degree or equivalent and internship senior projects or thesis in Engineering or Scientific field including either industry or industry/education
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 required
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
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 (CA) the base pay range for this position is $87000 to $123000 (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.
Required Experience:
IC
Key Skills
About Company
Edwards Lifesciences (NYSE: EW), is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakehol ... View more
