
Engineer I, Manufacturing Quality Assurance
4 days ago
Join to apply for the Engineer I, Manufacturing Quality Assurance role at Edwards Lifesciences . 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.
How you will make an impact:
- Investigate basic 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; analyze results, make recommendations and develop reports
- Optimize 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
- May develop, update, and maintain technical content of risk management files
- 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; give instruction to technicians on conducting tests; train technicians and provide feedback; and may coordinate technician work
- Other incidental duties assigned by Leadership
What you'll need (Required):
- Bachelor's Degree in Engineering or Science field, or Master's Degree or equivalent in Engineering or Science field
- Good computer skills in MS Office; 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
- Strong 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
- Attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast-paced environment
- Team-oriented with ability to work with immediate supervisor and other team members
- Ability to build stable working relationships internally
- Adherence to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and commitment to safety and environmental protection
- Seniority level: Entry level
- Employment type: Full-time
- Job function: Engineering and Information Technology
- Industries: Medical Equipment Manufacturing
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