EPS Connects LLC · 1 day ago
Senior Research And Development Engineer
EPS Connects LLC is seeking an experienced Senior R&D Engineer to drive innovation and lead development of advanced bioprocessing technologies. This role involves designing complex assemblies, advancing new product development, and supporting commercialization within a regulated environment.
Responsibilities
Lead product development from concept through commercialization
Design and develop single-use and fluid-handling components and assemblies
Drive innovation, prototyping, testing, and validation activities
Partner cross-functionally with engineering, quality, and scientific teams
Perform FMEA risk assessments and support design reviews
Ensure compliance with GMP and applicable regulatory standards
Support CAPA, ECR/ECO processes, and continuous improvement initiatives
Qualification
Required
Bachelor's degree in Mechanical, Biomedical, Electrical, or related Engineering field
7+ years in biotech, pharma, or regulated manufacturing environments
Strong Single-Use Technology (SUT) design experience (tubing, bags, filling needles preferred)
Expertise in molded plastics and fluid-handling applications
Knowledge of ISO 13485, ASME BPE, or similar standards
Hands-on CAD experience (2D/3D) and prototyping/validation background
Experience working in GMP environments