Research & Development Engineer

Our client, a clinical-stage medical device company focused on advancing transseptal left atrial appendage (LAA) closure, is in the process of a design transfer. They are seeking R&D Engineers with 6-10 years of experience to play a key role in the design, development, and manufacturing transfer of a left atrial appendage closure system.

Key Responsibilities

• Apply mechanical and biomedical engineering principles in the design and development of the LAA closure system.
• Conduct root cause analysis, evaluations, and technical troubleshooting to resolve design and manufacturing challenges.
• Create and execute experiments to assess product design performance, including fatigue testing and material analysis (e.g., nitinol components).
• Develop design documents, establish tolerances, and define product specifications.
• Collaborate with external suppliers to ensure seamless product design and manufacturing.
• Write and execute test protocols, analyze results, and provide detailed reports.
• Support the design transfer process by addressing manufacturing requirements, writing work instructions, and performing bench testing.
• Collaborate with Quality, Regulatory, Operations, and Clinical teams to ensure product success throughout its lifecycle.
• Contribute to resolving non-conforming material reports and ensure compliance with applicable regulations.
  
  

Qualifications

• 5-10 years of experience in R&D engineering, preferably in the medical device industry.
• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field (or equivalent experience).
• Hands-on experience in mechanical design, product development, fabrication, and evaluation, with a focus on medical devices.
• Expertise in fatigue testing protocols and experience working with nitinol components.
• Strong understanding of engineering first principles.
• Proficiency in 3D Solid Modeling and drawing (e.g., SolidWorks).
• Excellent communication skills, both written and verbal, with strong documentation abilities.
• Ability to work in a dynamic, fast-paced environment, demonstrating flexibility and adaptability.
• Strong interpersonal skills and experience working in cross-functional teams.