Senior Design Assurance Engineer (12 months Contract)

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:

As R&D Design Assurance Engineer in the field of innovative cardiovascular products, you will:

• 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 or Biomedical Engineering, or equivalent

• 3-5 years of experience in medical device field or equivalent

• 2 years of experience in R&D environment

• 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