Principal R&D Engineer

We are seeking an experienced Research and Development Engineer with deep medical device development expertise to serve as the technical Subject Matter Expert (SME) for catheter system design across multiple structural heart programs.

Requirements

• Bachelor's degree in Engineering required, ideally Mechanical or Biomedical; MS or PhD preferred with a minimum of 15+ years of experience in medical device design and development, including experience as a technical lead or project manager.
• Deep understanding of catheter mechanics, materials (polymers and metals), and bonding methods.
• Experience developing Class III implantable medical devices.
• Experience developing structural heart medical devices within an R&D environment.
• Strong understanding of mechanical engineering principles and methodologies.
• Leadership, task planning, and sub-team management experience.
• Strong communication, presentation, and technical writing skills, with the ability to effectively convey technical concepts and project plans to stakeholders at all levels.
• Knowledge of applicable standards including ISO 5840, ISO 13485, ISO 14971, ISO 10555, and ISO 10993.
• Strong design experience with CAD modeling software such as SolidWorks and/or Creo.
• Ability to create engineering specifications, technical drawings, and bills of material.
• Experience with manufacturing and assembly of complex prototypes.
• Experience with design verification planning, testing, and reporting to support early feasibility clinical studies and regulatory submissions.
• Strong data analysis and statistical skills using tools such as Minitab, JMP, or MedStat to support engineering decisions and regulatory documentation.

Benefits

• Medical, Dental, and Vision Plans
• Flexible Spending Account (FSA)
• 401k + Company Match
• Life, AD&D, Short Term and Long-Term Disability Insurance
• Bonus Plan Eligibility
• Employee Equity Program
• Paid Holidays & Vacation
• Employee Assistance Program