Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of ground-breaking 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.
The role:
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 will make an Impact:
Develop moderately complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyse results, make recommendations, and develop reports. (R&D: 30)
Develop, update, and maintain technical content of risk management files
investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyse results, make recommendations and develop reports. (MFG: 45 / R&D: 15)
Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma 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
Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
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 will need:
Minimum Bachelor's Degree in Engineering or scientific field
2+ years of relevant experience in a similar role
What else we look for:
Good computer skills in usage of MS Office Suite; CAD experience preferred
Basic documentation, communication and interpersonal relationship skills
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment preferred
Good understanding and knowledge of principles, theories, and concepts relevant to Engineering
Good problem-solving, organizational, analytical and critical thinking skills
Good 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 immediate supervisor and other team members in the section or group
Ability to build stable working relationships internally
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