The R&D engineer will work as a member of a multi-disciplinary team to develop and manufacture medical devices and their production space. Project scope may include new and next generation products, line extensions, manufacturing technology transfers, and general product improvements. Seeking an individual who can work with a team on complex tasks including product and process prototyping, testing, data analysis, report writing, and project planning.

Research

• Support biologic research including biologic product transfers and new biologic medical devices
• Update and improve current biologic manufacturing processes
• Research into new biological products including literature review, bench studies and early product developement.

Design & Development

• Develop prototypes, test methods, and production aids using SolidWorks
• Solve complex technical challenges related to product design and manufacturability
• Optimize designs for scalability and cost efficiency

Validation & Analysis

• Develop and execute validation protocols (IQ/OQ/PQ) and test methods
• Analyze test data using statistical tools to ensure designs meet performance and regulatory requirements
• Document and communicate results through clear technical reports

Required

• Bachelor’s degree in Bioengineering, Biomedical Engineering, Mechanical Engineering or related field
• 2-3 years of experience in engineering, preferably in medical devices or regulated industries
• Experience with validation (IQ/OQ/PQ) and design controls
• Understanding of statistical analysis and data-driven decision-making

Preferred

• Proficiency in SolidWorks
• Life Sciences background (cell, tissue, physiology, biochemistry, chemistry, etc.)
• Comfort with handling xenografts and allografts.

Additional Skills

• Strong problem-solving and critical thinking skills
• Excellent written and verbal communication
• Ability to balance multiple priorities in a fast-paced environment
• Effective collaborator across cross-functional teams

Additional Information

• Travel up to 15% (including occasional surgical case observation)