Senior Engineer, NPD Quality

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

Job summary

Edwards Lifesciences seeks a Senior Engineer, NPD Quality in Irvine, CA to drive quality for new product development in cardiovascular devices.

You will apply quality engineering principles, develop design control documentation, manage risk content and collaborate with R&D, Manufacturing, Regulatory and Clinical teams to ensure compliant, robust product launches and continuous improvement.

Qualifications

• Bachelor's degree in Engineering or a Scientific field with 4 years of related industry experience or a Master's degree with 3 years of related industry/education experience
• Strong documentation, communication, and interpersonal skills; ability to manage complex information and regulatory requirements
• Good understanding of statistical techniques and familiarity with lab/industrial equipment is beneficial
• Experience with design control documentation and risk management in medical device development preferred

Responsibilities

• Apply quality engineering principles to ensure regulatory compliance for new product development
• Develop, update, and maintain design control documentation throughout the product development process
• Maintain and update risk management and usability files
• Collaborate with R&D, Manufacturing, and cross‑functional teams to drive process and test method development and product launches
• Investigate complex product quality and compliance issues (CAPA, non-conformances, audits) during NPD
• Identify opportunities for design for manufacturing and continuous process improvement, including equipment/tools redesign

Skills

Documentation

Communication skills

Problem solving

Analytical thinking

Leadership

Team collaboration

Interpersonal skills

Regulatory understanding

Education

Bachelor's degree in Engineering or a Scientific field

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

Tools

MS Office

MS Project

CAD

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; ORMaster's degree or equivalent in Engineering or a Scientific field and 3 years of related industry or industry/education experienceWhat 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/controlAligning 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.