Engineer II, New Product Development Quality, TMTT

Edwards Lifesciences; Irvine (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Edwards Lifesciences in California is seeking a Quality Engineer to apply quality engineering principles to ensure regulatory compliance and to optimize product development, internal and external device manufacturing, and distribution.

You will develop and validate complex test methods, maintain risk management files, collaborate with R&D and Clinical Development, and drive continuous improvement using SIX Sigma and LEAN, while ensuring high integrity and safety across the product lifecycle.

Qualifications

• Bachelor's Degree in Engineering or Scientific field and 2 years’ related work experience OR
• Master's Degree or equivalent in Engineering or Scientific field including industry or industry/education
• Experience with test method development and validation

Responsibilities

• Develop and validate complex test methods to create, validate, and improve products and manufacturing processes based on engineering principles; analyze results, make recommendations, and develop reports.
• Develop, update, and maintain technical content of risk management files
• Work closely with R&D and Clinical Development to collaborate on project deliverables and meeting timelines
• Engage on design assurance and reliability related activities
• Investigate manufacturing product quality and compliance issues (CAPA, non-conformances, audit observations) for all production processes before final release
• Optimize manufacturing processes using SIX Sigma and LEAN methods for design for manufacturing and continuous process improvement
• Develop training and documentation materials for production to enable knowledge transfer
• Assign support tasks; instruct technicians on tests; coordinate technician work
• Other incidental duties assigned by Leadership

Skills

Documentation skills

Communication skills

Interpersonal skills

Negotiation

Relationship management

Problem solving

Analytical thinking

Attention to detail

Team collaboration

Education

Bachelor's Degree in Engineering or Scientific field

Master's Degree or equivalent in Engineering or Scientific field

Job description

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 optimize product development, internal and external device manufacturing, and device distribution.

How you will make an impact:

• Develop and validate complex test methods (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.
• Develop, update, and maintain technical content of risk management files
• Work closely with R&D and Clinical Development to collaborate on project deliverables and meeting timelines.
• Engage on design assurance and reliability related activities.
• Investigate moderately 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.
• Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• 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 you'll need (Required):

• Bachelor's Degree in Engineering or Scientific field, 2 years’ experience related work experience OR
• Master's Degree or equivalent in and internship, senior projects or thesis in Engineering or Scientific field including either industry or industry/education
• Experience with test method development and validation

What else we look for (Preferred):

• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Experience with risk management documentations (i.e., RMW, DFMEA)
• 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, the base pay range for this position is $85,000 to $120,000 (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.