Lead Biomaterials Process Development Engineer

Workforce Genetics; Baltimore (MD); On-site; USD 120,000 - 180,000; Full time

Job summary

LifeSprout is seeking an experienced Process Development Engineer to lead scaling and validation of biomaterial and device manufacturing. You will design experiments, optimize processes, and drive transfer from lab to production while ensuring regulatory compliance.

The role requires hands-on work in a fast-paced, regulated environment with collaboration across R&D, manufacturing, quality, and suppliers. Onsite work in the U.S. supports patient-focused product development.

Qualifications

• BS or MS in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Materials Science, or related engineering discipline.
• 5+ years of hands-on process development, scale-up, or validation in regulated environments.
• Experience with DOE, statistical analysis, process capability concepts, and experimental design.
• Strong written and verbal communication; cross-functional collaboration.

Responsibilities

• Lead process development, scale-up, optimization, and manufacturing transfer for biomaterial and medical device processes.
• Design and execute lab, pilot-scale, and production-scale studies to establish process windows and robustness.
• Apply DOE and data analysis to evaluate performance and guide decisions.
• Develop process descriptions, protocols, risk assessments, and validation plans aligned with GMP/ISO13485.

Job description

LifeSprout is seeking an experienced Process Development Engineer to lead scaling and validation of biomaterial and device manufacturing. You will design experiments, optimize processes, and drive transfer from lab to production while ensuring regulatory compliance.

The role requires hands-on work in a fast-paced, regulated environment with collaboration across R&D, manufacturing, quality, and suppliers. Onsite work in the U.S. supports patient-focused product development.