Senior R&D Engineer I - Remote

Overview

The Senior R&D Engineer I will lead research and development efforts for complex medical devices, focusing on innovative design, prototype development, and cross-functional collaboration.

In Short

• Design and develop new medical devices and processes.
• Lead cross-functional teams in product development.
• Conduct testing and validation of new products.
• Write and review technical documents and reports.
• Mentor R&D technicians and engineers.
• Manage project budgets and cost analysis.
• Utilize statistical methods for process development.
• Ensure compliance with regulatory guidelines.
• Participate in root cause analysis for design and process issues.
• Support training on new design and process methodologies.

Requirements

• B.S. degree in Mechanical, Biomedical, or Chemical Engineering.
• 6-9 years of experience in R&D or process development.
• Experience in FDA/QSR regulated environments.
• Hands-on technical aptitude and experience in process validation.
• Excellent communication skills.
• Proficient in statistical software.
• Training in Six Sigma or Design for Six Sigma is preferred.
• Knowledge of cGMP and GLP is a plus.
• Experience with combination devices and PMA processes is beneficial.

Benefits

• Opportunity to work on innovative medical technology.
• Supportive work environment for personal and professional growth.
• Engagement in meaningful projects that improve health outcomes.
• Collaboration with diverse teams across the globe.
• Competitive salary and benefits package.
• Flexible work-life balance options.