Senior Quality Design Assurance (Temporary for six month)

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world. How you will make an impact : Quality team member, allocated to R&D project as Design Assurance Engineer in the field of innovative cardiovascular products.
Perform quality activities per ISO 13485/FDA 21 CFR part 820 related to design control (e.g., design requirements, risk management, design verification and validation, design reviews)
Generate and/or review documents such as: design documents, drawings, work instructions, root cause analysis
Support R&D activities of early-stage development (e.g., root cause analysis, testing, documentation) What you’ll need (Required):
B.Sc. in Mechanical Biomedical Engineering, or equivalent
3- 5 years of experience in medical device field or equivalent
Quality Management System experience in medical devices
High technical skills, hands-on
Great interpersonal relationship
Proficient in English and technical writing
Organized and meticulous, detailed-oriented
Strong problem-solving and critical thinking skills
Independence and prioritizing abilities What else we look for (Preferred):
Cardiovascular medical device experience
Knowledge in statistical techniques
Project management experience in medical devices
Former employee of a large international company / Interactions with business units in US