Principal R&D Engineer

Primary Duties and Responsibilities

• Own technical decision-making for catheter architecture, materials, tolerances, and initial process development.
• Develop and execute design verification and validation strategies, including test method development and data analysis.
• Work collaboratively with cross-functional teams to drive product development from concept through commercialization while following documented design control processes, conducting risk management activities, and ensuring regulatory compliance.
• Evaluate design risks using tools such as FMEA, tolerance analysis, and failure investigations.
• Provide technical leadership in design reviews, risk assessments, and cross-functional forums.
• Partner closely with physicians and advisory board members to identify clinical and user needs and design innovative solutions.
• Lead definition of product design input requirements and translate them into mechanical designs, engineering documentation, and verification testing.
• Work closely with suppliers to ensure components meet design requirements, diagnose design issues, and collaborate to develop solutions.
• Present program progress, technical decisions, and development milestones to executives, external partners, and advisory board members.
• Drive continuous improvement of internal and external processes related to product development and manufacturability.

Skills, Knowledge, Experience & Qualifications

• Required Qualifications:
• 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.
• 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.
• Preferred Qualifications:
• Familiarity with manufacturing scale-up and process validation.
• Experience developing minimally invasive transcatheter heart valve repair or replacement devices.
• Familiarity with cardiac anatomy and physiology.
• Knowledge of catheter design and manufacturing processes including extrusion, braiding, and laser-cut hypotubes.
• Familiarity with human factors and systems engineering principles.
• Understanding of biocompatible materials and their mechanical properties.
• Experience collaborating with external contract manufacturing partners to design and build custom components.
• Preclinical study experience.
• Experience mentoring engineers and contributing to team development.
• Experience working in a startup environment or emerging technology space.

Compensation

• Target base salary range: $145,000 – $165,000, plus eligibility for an annual short-term incentive (STI) targeted at 10% of base salary and equity participation.
• Final compensation will be determined based on experience and alignment with role requirements.
• Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.

What We Offer

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Collaborative and dynamic work environment with a culture of innovation and excellence.
• Competitive compensation package, including salary, performance-based bonuses, and stock options.
• Career development opportunities and a chance to be part of a growing company that values its employees.
• Health and Wellness Offerings:
• 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
• Inclusive Team Environment

Note

• We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.