Engineer II, Quality

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world. 

Applies 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'll make an impact:
• Investigate moderately complex manufacturing product quality and compliance issues which may include:
• Investigate PRAs and complaints for manufacturing related issues
• Manage site NCRs, CAPAs , ECRs and audit observations for all production processes prior to final product release based on engineering principles; analyze results.

• Provide technical support to external land internal audits.
• Make recommendations and develop reports.
• Oversee product release, assess and disposition product onhold (MRB), and manage material quality control.
• Review and approve equipment validations and asset management actions.
• Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma, TOPP 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 reduce risk
• Collaborate with engineering teams to ensure successful transfers
• May develop, update, and maintain technical content of risk management files, review and revise pFMEAs in conjunction with BU PMS team where applicable for the plant site.
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Provides support to the following:
• Process validation or support/lead TMV
• Sustaining Quality Engineering responsibilities such as review Quality Metrics, Material Review Boards, Quality Control etc
• PMV, Process Validation plans
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Other incidental duties assigned by Leadership

What you'll need (Required):
Bachelor's Degree in Engineering or Scientific field, 2 years of experience or
Master's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or education

What else we look for (Preferred):
• Good computer skills in usage of MS Office Suite; CAD experience preferred
• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Quality systems
• 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 the ability to manage vendors and project stakeholders
• Ability to build productive internal/external working relationships
• 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