Senior Quality Engineer NPDDesign Assurance
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Job Location:
Irvine, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
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 this role you will apply your knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards systems/procedures to oversee quality for new product development.
How you will make an impact:
Develop update and maintain design control documentation through product development processes. Support development of design requirement documentation.
Develop update and maintain technical content of risk management files
Collaborate with R&D manufacturing and other cross-functional stakeholders to drive process and/or test method development product builds clinical programs design transfer and product launch. Participate in design verification and validation testing.
Investigate complex product quality and compliance issues (e.g. device evaluations CAPA non-conformances audit observations PRAs) during new product development based on engineering principles; analyze results make recommendations and develop reports.
Identify opportunities for re-design/design of basic equipment tools fixtures etc. to improve manufacturing processes and/or test methods and reduce risk.
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 youll need (Required):
Bachelors Degree in in Engineering or related field 4 years related industry experience or
Masters Degree or equivalent in in Engineering or related field 3 years experience related industry or industry/education experience or
Ph.D. or equivalent in in Engineering or related field 0 years experience
What else we look for (Preferred):
Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
Strong 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)
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 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 inter-departmental teams and key contact representing the organization on contracts or projects
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 $108000 - $153000 (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:
Senior IC
Key Skills
- Continuous Integration
- APIs
- Jenkins
- Test Cases
- Performance Testing
- Quality Assurance
- Agile
- Jira
- Software Testing
- Java
- Test Automation
- Selenium
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
