Jobs at Cresilon, Inc.

The Senior Process Engineer will lead manufacturing process development and optimization, ensuring quality and compliance for medical device products, while collaborating with cross-functional teams and providing technical leadership.

Lead and grow a multidisciplinary R&D team to develop polymer-based hemostatic medical devices from concept through scale-up, regulatory submission, and commercial launch. Drive technology scouting, stage-gate NPI execution, process validation, documentation, and cross-functional collaboration with Manufacturing, Quality, Regulatory, and Commercial teams. Recruit talent, manage budgets/schedules, secure non-dilutive funding, and publish peer-reviewed research.

Lead and manage preclinical research operations including in‑vivo safety and efficacy study design, CRO/vendor management, regulatory strategy, protocol/report authorship, and budgeting. Ensure compliance with GLP/GMP, ISO and FDA requirements, oversee large-animal surgical models, mentor junior staff, and publish research to support Class I–III medical device approval and commercialization.