Senior Engineer, NPD Quality

Edwards Lifesciences; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Senior Engineer, NPD Quality to drive quality for new product development in cardiovascular devices. You will partner with R&D, Manufacturing, Regulatory, and Clinical teams to ensure design controls, risk management, and reliable product launches.

Responsibilities include maintaining design history files, supporting verification/validation, applying Six Sigma/Lean to improve processes, and mentoring technicians while ensuring FDA and internal

Qualifications

• Bachelor’s or Master’s in engineering/science required or equivalent
• Strong documentation and communication skills are essential
• Experience with design controls and regulatory understanding a plus
• Familiarity with FDA regulations for medical devices preferred
• Ability to lead and train technicians and collaborate cross-functionally

Responsibilities

• Apply quality engineering principles to ensure regulatory compliance and Edwards procedures for new product development
• Maintain design control documentation and support design requirements documentation
• Maintain risk management and usability documentation
• Collaborate with R&D, Manufacturing and other stakeholders to drive process and test method development and product launches
• Investigate complex quality issues during development and recommend corrective actions
• Apply Six Sigma/Lean to optimize processes and equipment for manufacturing and testing

Skills

MS Office Suite

MS Project

CAD

Documentation & Communication

Leadership

Problem-solving

Teamwork

Education

Bachelor’s degree in Engineering or a Scientific field

Master’s degree or equivalent in Engineering or a Scientific field

Tools

CAD experience

Job description

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Engineer, NPD Quality , position is a unique career opportunity that could be your next step toward an exciting future.

Imagine how your ideas and expertise can change a patient’s life. Our New Product Development Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with Manufacturing, Clinical, Regulatory, and R&D teams, delivering thoughtful solutions to complex challenges while expanding your knowledge of the medical device industry.

You Will Make an Impact By:

• Applying knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards systems/procedures for new product development.

• Developing, updating, and maintaining design control documentation throughout the product development process; supporting the creation of design requirement documentation.

• Developing, updating, and maintaining the technical content of risk management and usability files.

• Collaborating 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; participating in design verification and validation testing.

• Investigating 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; analyzing results, making recommendations, and developing reports.

• Identifying and ensuring the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., Six Sigma, Lean) to support design for manufacturing and continuous process improvement; identifying opportunities for the design or redesign of equipment, tools, fixtures, and related components to improve manufacturing processes and/or test methods and reduce risk.

• Assigning support tasks and providing instruction to technicians on conducting tests; training technicians and providing feedback; coordinating technician work as needed; and training, coaching, and guiding lower-level employees on routine procedures.

• Performing other incidental duties as assigned.

What You’ll Need (Required):

• Bachelor’s degree in Engineering or a Scientific field and 4 years of related industry experience; OR

• Master’s degree or equivalent in Engineering or a Scientific field and 3 years of related industry or industry/education experience

What Else We Look For (Preferred):

• Proven expertise using the MS Office Suite, including MS Project; CAD experience preferred (if applicable).

• Strong documentation, communication (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 (if applicable).

• Substantial understanding and knowledge of engineering principles, theories, and concepts relevant to the role.

• Strong problem-solving, organizational, analytical, and critical-thinking skills.

• Substantial understanding of the processes and equipment used in assigned work.

• Good leadership skills and the ability to influence change.

• Knowledge of applicable FDA regulations for the 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.

• Ability to work effectively in a team environment, including inter-departmental teams, and to serve as a 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.