Job Information
Edwards Lifesciences Principal Engineer, Quality - Critical Care in Irvine, California
BD recently completed the acquisition of the Edwards Critical Care business. This position is part of the Critical Care division, and as such, will become a part of the BD organization in the future. BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. If you are invited to interview for this position, a recruiter will provide further details about this exciting transition. Learn more about BD at bd.com
Applies 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.
This Principal Quality Engineer will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and quality systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
How You Will Make an Impact:
Leads design assurance and development activities (i.e., requirement development, risk assessment, engineering study, feasibility testing, drawing review, etc.) for New Product Development programs
Provides engineering solutions in the areas of Quality Assurance, Design Control, Risk Management, and Statistical Techniques.
Develop, update, and maintain technical content of risk management files
Collaborates cross-functionally (eg. R&D, Mfg/Ops, Regulatory) to help facilitate the successful execution of the NPD process and launching of robust products
Develop and validate complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.
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.
Lead identification, development, and optimization of design verification activities and complex manufacturing processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) for design for manufacturing and continuous process improvement initiatives. Identify opportunities & implement solutions for re-design/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc. to
Assigns tasks; gives instruction to technicians on conducting tests; trains technicians and less seasoned engineers and provides feedback; and may coordinate engineer work.
Other incidental duties assigned by Leadership
What You’ll Need (Required Qualifications):
Bachelor's Degree in in Engineering or Scientific field , 6 years experience including either industry or industry/education Required or
Master's Degree or equivalent in in Engineering or Scientific field, 5 years experience including either industry or industry/education Required or
Ph.D. or equivalent in in Engineering or Scientific field, 2 years experience including either industry or industry/education Required
Hands-on experience with Design Assurance, including Design Controls, Design Freeze (or pre-design testing), Design Verification & Validation, and/or Design Test Method Development
Experience working within a highly regulated industry
What Else We Look For (Preferred):
Knowledge of and experience with Risk Management/Usability Engineering and authoring risk management documents.
Demonstrated technical leadership (i.e., solving complex problems; implementing a process or Quality improvement; piloting/creating new methodologies)
In-depth working knowledge and understanding of statistical techniques
Ability to read and interpret drawings
Ability to translate technical information to all levels of the organizations
Test Method Development and Validation Experience
Working knowledge of the Domestic and International regulatory requirements of Medical Device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366; and other applicable regulatory requirements)
Knowledgeable with MDR regulations
Strong technical writing skills
Ability to manage competing priorities in a fast paced environment
Work is performed independently while exercising considerable latitude in making significant decisions
Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts
Represents organization in providing solutions to difficult technical issues associated with specific projects
Develops technical solutions to complex problems which require the regular use of creativity
Uses best practices and knowledge of internal or external business issues to improve products/services or processes
Typically resolves complex problems or problems where precedent may not exist
Travel Requirements: % not specified, but travel has occurred in the past on an as-needed basis for project continuity
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 $115,000 to $163,000 (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.