Principal Engineer, Quality

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.

Key Responsibilities

• Lead identification, development, and optimization of 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 improve manufacturing processes and reduce overall process/product risk profile.

• Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and establish robust manufacturing processes/methods based on engineering principles; ensure completion of comprehensive process validations (IQ/OQ/PQ), including analyzing results and developing reports; collaborate with cross-functional team members to facilitate project success and on-time completion

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

• Develop technical content of risk management files

• Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., SCAR, CAPA, non-conformances, audit observations) for all supplier production processes and based on engineering principles; analyze results, make recommendations and develop reports

• Train, coach, and guide lower level employees on more complex procedures

• Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.

• Other incidental duties

Education and Experience

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

Additional Skills

• Proven expertise in usage of MS Office Suite

• Ability to read and interpret drawings

• Proven expertise in statistical techniques

• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills

• Ability to translate technical information to all levels of the organizations

• Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)

• Knowledge of Six Sigma concepts with ability to apply to work product

• Knowledge of Quality Engineering concepts with ability to apply to work product

• Advanced problem-solving, organizational, analytical and critical thinking skills

• Extensive understanding of processes and equipment used in assigned work

• Strong leadership skills and ability to influence change

• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Ability to manage competing priorities in a fast paced environment

• Work is performed independently while exercising considerable latitude in making significant decisions

• Set policies and standards that are followed by others

• Guides others in resolving basic issues in specialized area based on existing solutions and procedures

• 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

• 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

• Experience with automation, software testing, and software validation is strongly preferred

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 $106,000 to $151,000(highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Edwards 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.

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.