Edwards is looking to solve the problem of ensuring the highest standards of integrity and safety in the development of groundbreaking technologies for patients with mitral and tricuspid heart valve disease.
Requirements
- Basic understanding of statistical techniques
- Previous experience working with lab/industrial equipment
- Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Knowledge of and adherence to Quality systems
- Experience working in a manufacturing environment
- Experience working in a highly regulated industry, medical device industry experience preferred
Responsibilities
- 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; analyze results, make recommendations and develop reports.
- 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.
- 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; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
- Other incidental duties assigned by Leadership
Other
- Bachelor's Degree in an Engineering or Scientific field with 2 years of previous related work experience required
- Master's Degree or equivalent with internship, senior projects or thesis in an Engineering or Scientific field required
- Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
- Ability to interact professionally with all organizational levels
- Must be able to work in a team environment
