
Aortic Endovascular Repair System Designer
7 days ago
Design and develop cutting-edge medical devices that revolutionize the treatment of complex aortic aneurysms and dissections. Collaborate with cross-functional teams to bring forward novel solutions that address significant unmet patient needs.
Key Responsibilities:
- Contribute to the design, development, and refinement of next-generation aortic endovascular repair systems.
- Support feasibility studies, prototype development, and functional testing.
- Assist in defining and executing verification and validation plans to ensure compliance with regulatory requirements.
- Collaborate closely with clinical, regulatory, quality, and manufacturing teams.
- Participate in risk management activities, including FMEA and design hazard analysis.
- Document design controls in line with internal and external standards.
- Engage in iterative design processes using input from clinical experts, pre-clinical testing, and simulation data.
- Contribute to the preparation of technical documentation for regulatory submissions and design reviews.
- Stay up-to-date on emerging trends in endovascular technologies and aortic repair therapies.
Qualifications and Skills:
- Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or a related field.
- 1–5 years of experience in medical device design and development (preferably within cardiovascular or endovascular domains).
- Hands-on experience with CAD tools and rapid prototyping techniques.
- Understanding of anatomy and physiology relevant to vascular/aortic systems is a strong plus.
- Strong analytical and problem-solving skills with a creative, innovation-driven mindset.
- Excellent communication and teamwork abilities.
- Experience working in a regulated environment desirable.
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