Engineer, R&D

LeMaitre•Burlington, MA

1d•$100,000 - $115,000

About The Position

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.

Requirements

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
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

Nice To Haves

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

Responsibilities

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.
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
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