Mechanical Design Engineer

About the Company

Coramaze Technologies is committed to improving the lives of structural heart patients 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 Mechanical Design Engineer to join our R&D team, reporting to the VP of R&D. The Mechanical Design Engineer will be responsible for designing, prototyping, and optimizing mechanical components of the cardiac implant and delivery system. This role requires expertise in material selection, manufacturability, and innovation. 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:

• Design and develop detailed mechanical components for the implant and delivery system.

• Perform mechanical simulations, prototyping, and tolerance analyses to validate designs.

• Provide material expertise, ensuring biocompatibility and performance requirements.

• Collaborate with the production team to optimize designs for manufacturability and assembly.

• Create and maintain technical documentation, including drawings, BOMs, and specifications.

• Contribute to innovation by exploring new materials, technologies, and design approaches.

• Work closely with regulatory and quality teams to ensure product compliance with medical device regulations (FDA, ISO 13485, etc.).

• Contribute to design reviews and provide technical input.

• Stay current with advancements in cardiovascular technologies and apply industry best practices to medical device design.

Qualifications:

• Bachelor’s degree in Mechanical Engineering or related field. Master’s degree preferred.

• 5+ years of experience in medical device development, preferably with a track record of transcatheter cardiovascular or implantable devices.

• Full proficiency in CAD software (e.g., SolidWorks) and mechanical simulation tools.

• Hands-on experience with Nitinol shape forming and Pebax catheter manufacturing

• Familiarity with manufacturing processes, including injection molding, machining, extrusion, etc.

• Knowledge of ISO 13485, FDA, or MDR regulations is a strong plus.

• Excellent analytical problem-solving and communication skills (proficiency in written and spoken English) with the ability to work collaboratively in a fast-paced environment.

• Enthusiastic, passionate personality that loves taking initiative and driving actions to completion!

Up for the challenge? Send your CV directly to: [email protected]