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Senior Quality Engineer - NPD/Design Assurance

Edwards Lifesciences

Irvine, CA

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JOB DETAILS
SALARY
$108,000–$153,000 Per Year
SKILLS
Analysis Skills, Coaching, Communication Skills, Compensation and Benefits, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Design Verification, Detail Oriented, Document Management, Documentation, Environmental Health, FDA Requirements, Healthcare Providers, Interpersonal Skills, Laboratory, Laboratory Equipment, Maintain Compliance, Manufacturing, Manufacturing/Industrial Processes, Medical Equipment, Medical Products, Microsoft Office, Microsoft Project, Pollution Prevention, Problem Solving Skills, Process Improvement, Product Design, Product Development, Product/Service Launch, Quality Assurance Methodology, Quality Engineering, Quality Management, Regulatory Compliance, Regulatory Requirements, Relationship Management, Reporting Skills, Requirements Management, Research & Development (R&D), Risk Management, Safety Standards, Safety/Work Safety, Sales Management, Team Player, Technical Writing, Test Plan/Schedule, Training/Teaching, Vaccination, Validation Testing
LOCATION
Irvine, CA
POSTED
30+ days ago
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. In 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 you'll need (Required):

• Bachelor's Degree in in Engineering or related field, 4 years related industry experience or

• Master's 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 $108,000 - $153,000 (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 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.

About the Company

E

Edwards Lifesciences