Senior Engineer, 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 complex manufacturing product quality and compliance issues which may includes: - Investigate PRAs and complaints for manufacturing related issues.
- Manage site NCRs, CAPA, 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.
• Identify and ensure the optimization of complex Manufacturing and/or R&D 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.
• Oversee product release, assess and disposition product onhold (MRB), and manage material quality control, manufacturing / process changes (not related to design).
Review and approve equipment validations and asset management actions.
• Develop, update, and maintain technical content of risk management files, review and revise pFMEAs in conjunction with BU PMS team
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Provides lead and guidance to the following:
-Support process validation or support/lead TMV
- Lead sustaining Quality Eengineering responsibilitie such as, reivew Quality Metrics, Material Review Boards, Qaulity control etc
- Lead TMV, Process Validation plans
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
Train, coach, and guide lower level employees on routine procedures.
• Other incidental duties assigned by Leadership

What you'll need (Required):
Bachelor's Degree in Engineering or related field, 4 years related industry experience or Master's Degree or equivalent in Engineering or related field, 3 years related industry experience or Ph.D. or equivalent in Engineering or related field, 0 years related industry experience

What else we look for (Preferred):
• Working knowledge and understanding of statistical techniques will be required for work related plant sites
• Manufacturing Engineering and/or Process Validation background preferred
• Proven ability to apply Engineering/Scientific theory
• Strong problem-solving, organizational, analytical and critical thinking skills
• Excellent verbal and written communication skills in English.
• Written and verbal communication skills in Spanish preferred
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• 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 inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• The Sr. Quality Engineer will need to be highly flexible and assume multiple engineering roles.  As the volume of work expands in Costa Rica, increased specialization of engineering positions will be more practical.
• This engineer will be expected to work closely with coaches and peers in Irvine, Singapore and Costa Rica to enable the flexible nature of this job.
• 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