Principal Engineer, Quality

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.  In this role, you will apply your knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

How you will make an impact:
• Investigate complex product quality and compliance issues ((e.g., Product Risk Assessments, CAPAs, non-conformances, audit observations)) based on engineering principles; analyze results, make recommendations and develop reports. 

• Execute timely complaint investigations utilizing a multifunctional approach and ensuring issues are addressed in a systematic, methodical manner. Provide detailed analysis of the process and data; determine root causes of the nonconformities in order to establish appropriate corrective and preventive actions. 

• Lead post-market surveillance activities to monitor safety, performance and effectiveness of products. Assess benefit-risk determination of devices throughout their entire life cycle. Complete review of post-market data and post market reporting activities (Eg. PSUR/PMSR) as required.
 • Execute risk management activities through-out the post-market phase and ensure compliance with regulatory requirements. Support, update, and maintain technical content of risk management files and ensure integration with other aspects of the quality system.

• Collaborate with cross-functional stakeholders (including supplier quality, R&D and manufacturing) and ensure oversight of quality issues that require investigation through the different phases. 

• Lead identification, development, and optimization of processes using engineering methods to drive continuous process improvement initiatives. 

• Train, coach, and guide lower-level employees on complex procedures. Oversee Quality support tasks; give instruction, provide feedback and coordinate work of other engineers.

• Other incidental duties as assigned by leadership

What you'll need (Required):
• Bachelor's Degree in Engineering or Scientific field, 6 years’ experience including either industry or industry/education or
• Master's Degree or equivalent in in Engineering or Scientific field, 5 years’ experience including either industry or industry/education or
• Ph.D. or equivalent in in Engineering or Scientific field, 2 years’ experience including either industry or industry/education 

What else we look for (Preferred):
• Proven expertise in usage of MS Office Suite; Electronic Quality Management System
• Proven expertise in statistical techniques
• Excellent documentation, 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 and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
• Knowledge of Six Sigma concepts with ability to apply to work product
• Knowledge of applicable FDA regulations for medical device industry
• 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
• Work is performed independently while exercising considerable latitude in making significant decisions
• Set policies and standards that are followed by others
• Guides others in resolving basic issues in specialized area based on existing solutions and procedures
• Must be able to work in a team environment, including frequent inter-organizational contacts
• Represents organization in providing solutions to difficult technical issues associated with specific projects
• Develops technical solutions to complex problems which require the regular use of creativity
• Uses best practices and knowledge of internal or external business