Senior Engineer, NPD-Quality

Regulatory Toolkit; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Benefits offered by this job

Competitive salary

Performance-based incentives

Benefits programs

Job summary

Edwards Lifesciences in California seeks a Quality Engineer to apply design control, risk management, and regulatory compliance across the product lifecycle. You will partner with R&D, manufacturing, and cross-functional teams to ensure safe, effective therapies and robust quality systems for cardiac surgery technologies.

We value strong communication, problem solving, and leadership, with opportunities to influence design transfers, testing, CAPA, and continuous process improvement within a

Qualifications

• Bachelor's Degree in Engineering or Scientific field with 4 years’ related industry experience.
• Master's Degree or equivalent in Engineering or Scientific field with 3 years’ related industry experience or industry/education experience.
• Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education

Responsibilities

• Develop, update, and maintain design control documentation through product development processes.
• Develop, update, and maintain technical content of risk management and usability 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 during new product development based on engineering principles; analyze results, make recommendations and develop reports.
• Identify and ensure the optimization of complex Manufacturing and RandD processes using SIX Sigma and LEAN methods for design for manufacturing and continuous process improvement.
• Assign support tasks; give instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Other incidental duties assigned by Leadership

Skills

Problem solving

Leadership

Communication

Analytical thinking

Education

Bachelor's Degree in Engineering or Scientific field

Master's Degree or equivalent in Engineering or Scientific field

Ph.D. or equivalent in Engineering or Scientific field

Tools

MS Office Suite

MS Project

CAD

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. Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

In this role, you'll apply quality engineering expertise to enable innovation while ensuring compliance with regulatory requirements and Edwards' quality systems. Every project presents new opportunities to tackle technical challenges, collaborate with diverse teams, and help bring safe, effective, and reliable therapies to patients around the world.

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 and usability 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., pre-commercial complaints, CAPA, non-conformances, audit observations, PRAs) during new product development based on engineering principles; analyze results, make recommendations and develop reports.
• Identify and ensure the optimization of complex Manufacturing and/or RandD 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/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 Qualifications):

• Bachelor's Degree in Engineering or Scientific field with, 4 years’ experience related industry experience or
• Master's Degree or equivalent in Engineering or Scientific field with, 3 years’ experience related industry or industry/education experience or
• Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education

What else we look for (Preferred Qualifications):

• 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 (CA), the base pay range for this position is $108,000 to $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.