Device Design Engineer for Innovative Medical Solutions
7 dagen geleden
About AMT Medical
">AMT Medical is a dynamic scale-up poised to redefine cardiac care. Our innovative Elana Anastomotic System enables surgeons to create a sutureless bypass on a beating heart without using a heart-lung machine, thereby reducing patient impact and speeding up recovery.
We are actively seeking a Medical Device Design Engineer to join our innovative team. As a key member of our engineering team, you will take charge of designing and developing Class III medical devices from concept through to production scale-up.
This role involves close collaboration with engineering partners and cross-functional teams to ensure that our products meet the highest standards of safety, efficacy, and quality.
Key Responsibilities:
- Design and Develop Implantable Devices: Ensure innovative solutions from concept to production, meeting regulatory requirements.
- Create Detailed Engineering Models: Drawings, specifications, and simulations to establish robust product specifications.
- Collaborate with Cross-Functional Teams: Define product requirements, ensure compliance with medical device regulations, and manage design verification and validation activities.
- Conduct Feasibility Studies: Design experiments, simulations, and risk assessments throughout the product development lifecycle.
- Develop Test Protocols: Document outcomes to demonstrate device performance and regulatory compliance.
- Engage in Design Reviews: Risk management sessions, and root cause analysis to optimize design.
- Provide Technical Support: Seamless manufacturing start-up, ensuring efficient production processes.
- Stay Abreast of Industry Trends: Advancements and regulatory changes impacting product design and compliance.
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