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Product Development Lead for Implantable Devices
1 week geleden
As a Product Development Lead for Implantable Devices at AMT Medical, you will play a critical role in shaping the future of cardiac care. Our mission is to transform Coronary Artery Bypass Surgery with our innovative Elana Anastomotic System.
The successful candidate will be responsible for leading human factors and usability engineering activities, working closely with engineering partners and cross-functional teams to ensure our products meet the highest standards of safety, efficacy, and quality.
The key responsibilities of this role include:
- Coordinating human factors/usability engineering activities with product development, quality, regulatory, manufacturing, and clinical teams.
- Developing use analysis in partnership with the risk management team.
- Driving product improvement by providing feedback on UX, functionality, and complaints handling.
- Conducting qualitative and quantitative research techniques.
- Creating usability engineering documentation, such as Usability Engineering File (UEF), Use Specifications, Task Analysis, and Use Error Analysis.
The ideal candidate will possess:
- A degree in Mechanical Engineering, Biomedical Engineering, or a related field.
- Product development, design, or engineering experience, preferably using ISO 13485 and ISO 14971.
- Demonstrated interest in medical devices, ideally with experience working within a medical device Quality Management System (ISO 13485).
