Senior System Engineer

Coramaze Technologies is committed to the improvement of structural heart patients’ lives by developing accessible and effective minimally invasive treatments. The Coramaze TriPair System brings healing to patients without access to alternative therapies.

We are currently seeking an experienced and driven System Engineer to join our team, reporting to the VP of R&D. In this role, you will collaborate closely with cross-functional teams, including engineering, quality, regulatory, and clinical, to bring our next-generation TriPair System to market.

Key Responsibilities:

• System-level integration and optimization of cardiovascular implants and delivery devices, from concept to final release.
• Develop qualified test methods, conduct and lead design verification and validation (V&V) activities, ensuring that system requirements are met.
• Support risk management activities, including FMEA, hazard analysis, and safety assessments.
• Work closely with regulatory and quality teams to ensure product compliance with medical device regulations (FDA, ISO 13485, etc.).
• Participate in design reviews, provide technical input, and ensure seamless integration of subsystems.
• Establish and validate production lines, including tooling and equipment; Implement quality control measures to ensure consistent product output.
• Interface with clinical teams to translate user needs into technical specifications.
• Stay current with advancements in cardiovascular technologies and apply industry best practices to system development.

Qualifications:

• Master’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
• 10+ years of experience in medical device development, preferably with a track record of transcatheter cardiovascular or implantable devices.
• Strong knowledge of system engineering principles, including requirements management, risk analysis, and system integration.
• Experience in V&V Testing and process validation, including writing technical documentation
• Proficiency in system modelling tools and CAD software.
• Excellent problem-solving skills with the ability to work collaboratively in a fast-paced environment.

Up for the challenge? send your CV to [email protected]