Jobs at Biolinq Incorporated

Reviews Device History Records, performs product and labeling inspections, leads production line audits, supports audit readiness, documents quality metrics, resolves discrepancies, and drives corrective actions and continuous improvement. The role ensures compliance with SOPs, ISO 13485, 21 CFR Part 820, and evolving quality-system requirements in a regulated medical-device clean-room production environment.

Manages quality document control activities, including change orders, training assignments, document and device history record numbering, logbooks, manufacturing records, and quality procedures. Supports NCMR and CAPA investigations, supplier management, departmental reporting, employee training, onboarding, and internal or external audits. Collaborates with engineering, manufacturing, quality, and other cross-functional teams in a regulated medical device environment.

Oversee daily manufacturing operations, production scheduling, staffing, training, safety, quality, delivery, and cost performance. Supervise and develop a multi-shift team, troubleshoot production issues, maintain GMP/GDP compliance, manage materials and inventory, analyze manufacturing data, support documentation and testing, and drive process efficiency and continuous improvement in a cleanroom environment.

Manage clinical studies from planning through readiness, including timelines, budgets, vendors, clinical sites, study documentation, training, monitoring, compliance, and regulatory submissions. Maintain inspection-ready trial files, support audits, resolve protocol deviations and product issues, and coordinate with Quality, Regulatory, Engineering, and Marketing. The role manages multiple concurrent studies in a lean medical-device environment and requires up to 50% travel.

Lead development and commercialization of intradermal biosensor software, authoring tested mobile/server/GUI code and SDKs, ensuring regulatory quality-system compliance, mentoring engineers, estimating capacity, and maintaining production services.

Lead setup and daily supervision of a pilot manufacturing line for a medical device, including equipment installation, IQ/OQ/PQ validation, SOP and DHR creation, staffing and scheduling, yield and inventory management, regulatory compliance (cGMP, FDA QSR, ISO 13485), continuous improvement, and cross-functional coordination with Engineering, Quality, and Supply Chain.

Design, implement, test, and maintain mobile/server/GUI software for a wearable biosensor platform. Work cross-functionally to define requirements, produce production-ready code and unit tests, maintain regulatory-quality documentation, estimate and deliver features, and support deployed applications.

Design, synthesize, and evaluate enzyme-based electrochemical biosensor architectures. Prepare reagents, run and calibrate automated electrochemical experiments, maintain lab safety and equipment, order materials, analyze in vitro/in vivo datasets using statistical methods, present results to the team, and collaborate with engineering and R&D to integrate and translate designs. Heavy on-site lab work (up to 90%).

Lead R&D design, testing, and optimization of microneedle and MEMS biosensor devices. Develop tests, in-silico models, and prototypes; work with manufacturers and cross-functional teams; perform statistical analysis and failure investigation; generate IP and support product commercialization for regulated markets.

Design, synthesize, and evaluate aptamer-based electrochemical biosensors; prepare reagents; run automated electrochemical experiments; analyze in vitro/in vivo datasets and statistics; maintain lab safety and equipment; order materials; present results; collaborate with engineering and R&D to translate designs.

Execute established R&D laboratory protocols, perform experiments and basic data analysis, manage lab inventory and compliance, maintain safety culture, train team members, and support biosensor development under senior guidance.