Principal R&D Mechanical Engineer

1 month ago

Santa Clara, United States Cortex Full time

Cortex EP is a clinical-stage medical device company developing an innovative heart catheter with integrated AI that aims to transform the diagnosis and treatment of atrial arrhythmias by providing insight into each individual patient’s disease pathophysiology. Our unique OptiMap System™ is a 510(k) cleared, advanced mapping system that calculates Electrographic Flow™ (EGF) from a single minute of unipolar electrogram signals recorded from our innovative basket catheter.


We have offices in the San Francisco Bay area as well as various locations in Europe. We are continuing to expand our trial locations in the US and Europe and have opportunities to join the team throughout the country.


Job Description:

We are seeking a highly skilled and experienced Principal R&D Mechanical Engineer to join our dynamic team. In this role, you will lead the design and development of advanced medical devices, from concept through to commercialization. You will be a key contributor to our R&D team, working on innovative projects that push the boundaries of medical technology.


Key Responsibilities:

  • Lead the mechanical design and development of new medical devices, ensuring compliance with regulatory requirements and industry standards.
  • Drive the innovation process, generating new ideas and concepts for next-generation medical devices.
  • Identify and resolve technical issues and challenges throughout the design and manufacturing process.
  • Perform detailed mechanical engineering analysis, including simulations, FEA, and tolerance analysis.
  • Oversee the creation of detailed design documentation, including CAD models, drawings, and specifications.
  • Collaborate with cross-functional teams, including software engineers, and regulatory affairs, to ensure cohesive product development.
  • Conduct risk assessments and develop mitigation strategies to ensure the safety and reliability of devices.
  • Manage and mentor junior engineers, providing guidance and support to foster their professional growth.
  • Stay current with industry trends and advancements, integrating new technologies and best practices into the R&D process.
  • Lead prototyping and testing activities, analyzing results and iterating designs to achieve optimal performance.
  • Coordinate with manufacturing teams to ensure seamless transition from development to production.
  • Present project updates and technical findings to senior management and stakeholders.


Qualifications:

  • Bachelor's or Master’s degree in Mechanical Engineering or a related field.
  • Minimum of 10 years of experience in mechanical engineering, with a significant portion in the medical device industry.
  • Proven track record of leading successful product development projects from concept to market.
  • Expertise in CAD software (e.g., SolidWorks, Pro/ENGINEER) and FEA tools.
  • Strong understanding of materials science, manufacturing processes, and design for manufacturability (DFM).
  • In-depth knowledge of medical device regulations and standards (e.g., ISO 13485, FDA 21 CFR Part 820).
  • Excellent problem-solving skills and a creative approach to engineering challenges.
  • Strong leadership and project management abilities.
  • Effective communication skills, both written and verbal, with the ability to present complex technical information clearly.
  • Ability to work effectively in a fast-paced, collaborative environment.


Preferred Qualifications:

  • Experience with implantable medical devices or minimally invasive surgical instruments, steerable catheter delivery systems preferred.
  • Familiarity with Design for Six Sigma (DFSS) and Lean principles.
  • Patents or published research in the field of medical device engineering.


Cortex is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.

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