Principal Engineer, NPD-Quality

Regulatory Jobs; Irvine (CA); On-site; USD 121,000 - 171,000; Full time

Benefits offered by this job

Competitive salary

Incentives

Benefits program

Job summary

Regulatory Jobs in California seeks a senior Quality Engineer to oversee design control documentation, risk management, and usability files within a robust quality system supporting medical device development. You will partner with engineers, clinicians, and cross-functional teams to ensure regulatory alignment and patient safety throughout the lifecycle.

Ideal candidates bring strong leadership, CAD experience, MS Office proficiency, and a deep understanding of quality engineering and

Qualifications

• Bachelor's Degree in Engineering or Science with 6 years' experience.
• Master's Degree or equivalent with 5 years' experience.
• PhD or equivalent with 2 years' experience.

Responsibilities

• Provide leadership to develop design control documentation across product development processes.
• Develop, update, and maintain risk management and usability files.
• Lead optimization of Manufacturing and R&D processes using engineering methods for design for manufacturing and continuous improvement.
• Drive development and execution of complex experiments and tests to create, validate, and improve products and establish robust test methods.
• Lead investigation of complex quality and compliance issues and support regulatory submissions and audits.
• Train and coach engineers/technicians on procedures and testing.
• Oversee Quality support tasks and collaboration across teams.

Skills

Design control

Risk management

Leadership

Problem solving

Interpersonal/communication

Education

Bachelor's Degree in Engineering or Science

Master's Degree or equivalent

Ph.D. in Engineering or Science

Tools

MS Office Suite

CAD

Quality systems

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.
Do you thrive on solving difficult problems and turning innovative ideas into life-changing therapies? Our New Product Development Quality team works at the intersection of innovation, risk management, and patient impact. Partnering with engineers, clinicians, and cross-functional teams, you'll help shape the development of breakthrough medical technologies by solving complex challenges, reducing risk, and influencing critical decisions throughout the product development process.
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:

• Provide leadership and oversight for a device, system, or project to 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
• Lead identification, development, and optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) for design for manufacturing and continuous process improvement initiatives. Identify opportunities and implement solutions for re-design/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc. to improve manufacturing processes and/or test methods, and reduce overall process/product risk profile.
• Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and establish robust processes and/or test methods based on engineering principles; ensure completion of comprehensive usability studies, design verification and validation, validations for process and test methods, including analyzing results and developing reports; collaborate with cross-functional team members to facilitate project success and on-time completion
• Lead in the investigation of complex product quality and compliance issues (e.g., pre-commercial complaints, CAPA, non-conformances, audit observations, PRAs) during new product development and based on engineering principles; analyze results, make recommendations and develop reports. Act as subject matter expert for internal and/or external audits for products and/or processes. Support regulatory submissions and addressing responses during regulatory reviews.
• Train, coach, and guide lower-level employees on more complex procedures. Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.
• Other incidental duties

What you'll need (Required Qualifications):

• Bachelor's Degree in in Engineering or Scientific field , 6 years’ experience, including either industry or industry/education or
• Master's Degree or equivalent in Engineering or Scientific field , 5 years’ experience, including either industry or industry/education or
• Ph.D. or equivalent in Engineering or Scientific field , 2 years’ experience, including either industry or industry/education

What else we look for (Preferred Qualifications):

• American Society for Quality Certification (ASQ) ASQ Certified Quality Engineer (CQE)
• Proven expertise in usage of MS Office Suite; CAD experience preferred
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
• Ability to translate technical information to all levels of the organizations
• Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering
• Advanced problem-solving, organizational, analytical and critical thinking skills
• Extensive understanding of processes and equipment used in assigned work
• Strong leadership skills and ability to influence change
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• 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 frequent inter-organizational and outside customer contacts
• Represents organization in providing solutions to difficult technical issues associated with specific 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 $121,000 to $171,000 (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.