Senior Engineer, NPD Quality

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

Job summary

Edwards Lifesciences in Irvine, CA seeks a Principal Quality Engineer, NPD to support the Transcatheter Heart Valve (THV) program. You will lead design control documentation, risk management files, and cross-functional design transfers to enable successful product development.

The role requires collaboration with R&D and manufacturing, and the ability to address complex quality and regulatory challenges. Candidates should have a relevant engineering or scientific degree with several years of

Qualifications

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

Responsibilities

• Develop, update, and maintain design control documentation through product development processes.
• Develop, update, and maintain risk management and usability files.
• Collaborate with R&D, manufacturing, and other cross-functional stakeholders to drive design transfer and product launches; participate in verification and validation testing.
• Investigate complex product quality and compliance issues during new product development and provide recommendations.
• Identify opportunities to optimize manufacturing and R&D processes using Six Sigma and LEAN methods.

Skills

Cross-functional collab

Leadership

Problem solving

Written/verbal comms

Education

Bachelor's in Engineering/Science

Master's in Engineering/Science

PhD in Engineering/Science

Tools

MS Office

MS Project

CAD

Job description

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

This Principal Quality Engineer, NPD will be part of Edwards Lifesciences growing Transcatheter Heart Valve (THV) business in Irvine, CA. We are looking for a strong engineer with solid technical expertise, who enjoys working in a fast paced and rapidly growing environment where taking initiative and collaborating cross-functionally are critical for success. The engineer will have a variety of responsibilities in New Product Development providing Quality Engineering support and leadership to ensure the successful design and development of new products. You will apply 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 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 R&D 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):

• 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):

• 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.