Teams at Nextern

Lead medical device manufacturing process development, validation, optimization, and continuous improvement. Develop technical documentation, procedures, work instructions, and validation reports compliant with FDA regulations and ISO 13485. Design fixtures, tooling, and production equipment; troubleshoot processes; conduct root cause analyses and CAPA; and collaborate with Quality, R&D, and Production teams on product launches.

Develop and maintain embedded software and firmware for regulated medical devices. Responsibilities include architecture, coding, documentation, integration and unit testing, defect resolution, risk analysis, configuration and release management, and verification support. The engineer will participate in technical reviews, improve software processes, act as a product owner or subject matter expert, and mentor junior engineers.

Leads the design, development, testing, and documentation of complex electrical and electronic systems for medical devices. Collaborates with multidisciplinary teams and clients, defines requirements, resolves technical issues, performs root-cause analysis, supports regulatory compliance, and mentors junior engineers. The role requires expertise in analog and digital circuitry, hardware design, testing, debugging, and embedded firmware development.