R&D Engineer II

We are seeking an R&D Engineer II to join a leading medical device team focused on the design, development, and launch of innovative structural heart products. This is an excellent opportunity for engineers with experience in product development, testing, and mechanical design within a regulated industry.

• Design, develop, prototype, test, and improve medical device components and systems.
• Develop test methods and execute protocol-based testing (DV, DVal, lot release, etc.).
• Lead root cause investigations and support failure analysis activities.
• Create and modify CAD models, assemblies, and technical drawings using Solid Works
  .
• Document engineering activities, including test protocols, reports, and characterization studies.
• Collaborate with cross-functional teams including Manufacturing, Quality, Regulatory Affairs, Clinical, and Marketing.
• Support design controls, process development, product validation, and regulatory submissions.

• Bachelor's degree in mechanical, Biomedical, Materials, or Chemical Engineering
  .
• 2+ years of engineering experience in R&D, product development, manufacturing, or quality within a regulated industry.
• Hands-on experience with Solid Works (part design, assemblies, and technical drawings).
• Experience with root cause investigations and mechanical prototyping.
• Knowledge of statistical analysis tools such as Minitab, tolerance analysis, t-tests, or normality analysis
  .
• Strong written and verbal communication skills.

• Experience with medical devices
  , especially catheter-based or structural heart products.
• Test method development and validation experience.
• Knowledge of Design of Experiments (DOE) and statistical techniques.
• Experience with design verification, validation, failure analysis, and process improvement.