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Salary: USD 130,000 - 165,000 / annual
Culture Biosciences is seeking a Manufacturing Engineer to support hardware manufacturing and single-use consumables production. The role bridges engineering and hands-on technician work, focusing on scaling prototypes from conception to higher manufacturing volumes, building hardware and single-use products on the manufacturing floor, and maintaining quality systems.
Key responsibilities include: scaling consumables and hardware engineering prototypes to higher manufacturing volumes; building hardware and single-use products directly on the manufacturing floor; writing manufacturing instructions and device history records; enhancing in-house manufacturing capabilities and quality systems; running deviation processes and quality checks across all builds, identifying root causes of hardware and single-use issues; partnering with R&D on design transfer; collaborating with engineers, technicians, and manufacturers to debug and optimize systems; developing and maintaining systems through user testing, training, and change control; and learning about fermentation, cell culture, and biomanufacturing processes.
This is a hands-on role requiring comfort moving between engineering and technician responsibilities, working independently, and owning projects. You will work closely with multidisciplinary teams spanning mechanical, electrical, chemical, software, and materials engineering to create new bioreactors, single-use assemblies, and automation systems.
Culture's platform merges products, services, and data management for mammalian, microbial, and viral vector production processes, enabling high-throughput process development projects executed by customers in their own facilities or Culture's service laboratories.
REQUIREMENTS:
- 8+ years of related manufacturing or engineering experience
- Bachelor's degree in Mechanical, Electrical, Biomedical Engineering, or related field
- Experience working in multidisciplinary team settings and bringing products from concept through market release and beyond
- Hands-on troubleshooting experience through design verification and validation
- Comfortable in both engineering and hands-on technician roles with strong mechanical aptitude and problem-solving skills
- Capable of clearly communicating engineering concepts, project status, and technical risk to other individuals and teams
- Self-driven with experience leading own projects and a leadership mindset
- Strong communication, organizational, and multitasking skills
- Plus: experience building test rigs, working in 3D CAD, writing simple test scripts, ERP/MES software experience