Engineer II, Quality

Edwards Lifesciences

Wet Plant, Cartago, Costa Rica

hace 2 horas

Applies knowledge of technical principles and Edwards systems / procedures to optimize manufacturing processes.Key Responsibilities :

Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and / or re-design / design of equipment, tools, fixtures, etc.

to improve manufacturing processes, employing technical design skills

Develop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes;

analyze results, make recommendations, and develop reports

Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)

Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes

Establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.

g., Project Plan, Risk Analysis, etc.)

Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback;

and coordinate technician work

Other incidental duties assigned by LeadershipEducation and Experience : Bachelor's Degree in Engineering or Scientific field, 2 years of experience Required orMaster's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry / education RequiredAdditional Skills :

Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)

Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

Basic understanding of statistical techniques

Previous experience working with lab / industrial equipment required (if applicable)

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 Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

Knowledge of applicable FDA regulations for medical device industry

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 EHS rules and requirements 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

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