- the research and development of critical sub-systems on an active implant system, from conceptualization and prototype development to design for manufacturing.
- feasibility studies, literature reviews, and technology assessments to inform the design and development process.
- with mechanical and electrical engineers to integrate components and systems, optimizing functionality and performance.
- test strategies and execute testing to evaluate the performance, reliability, and safety of implant prototypes.
- data, interpret results, and provide recommendations for design improvements and optimization.
- and maintain documentation including design specifications, test protocols, and regulatory submissions.
- closely with manufacturing partners to transfer designs into production, ensuring scalability and manufacturability.
- technical expertise and guidance to junior engineers and contribute to a culture of innovation and excellence within the team.
- Bachelor's degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or related field; Master's degree preferred.
- Minimum of 7 years of experience in research and development and/or prototype manufacturing preferably within the Class III implantable technology industry.
- Strong understanding of medical device design principles, materials science, and manufacturing processes.
- Experience with CAD (SolidWorks) design
- Experience with design control processes, including design verification and validation activities.
- Proficiency in data analysis tools and statistical methods for experimental design and analysis.
- Familiarity with regulatory requirements for medical devices (e.g., ISO 13485, FDA QSR) is a plus.
- Effective communication skills and the ability to work effectively in a cross-functional team environment.
- Fluency in English; French language proficiency is a plus.
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Ingénieur R&D sénior - Île-de-France - Antenor
Description
ANTENOR, the Healthcare and Life Sciences HR reference, meets the recruitment, assessment and coaching needs of rare, expert and managerial skills.
For our partner, an innovative start-up specializing in the medical field, we are looking for aSenior R&D Engineer (m/f).
As a Senior R&D Engineer, you will be an integral part of our R&D team, contributing your expertise to the design, development, preparation of manufacturing and optimization of our innovative active implant technology. You will be leading the development of critical components on the implanted system and collaborate closely with the cross-functional team (R&D, Quality, regulatory). This is a unique opportunity to join a fast-paced start-up environment and make a meaningful impact on the future of healthcare. This is a full-time opportunity and requires willingness to relocate to Paris, France.
Key Responsibilities:
Qualifications:
Experience with test method development, testing and validation of test methods.
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