Jobs at Nextern

Leads Nextern’s global end-to-end supply chain across sourcing, procurement, supplier management, planning, inventory, materials, warehousing, and logistics. Builds scalable global processes, systems, governance, KPIs, and organizational capabilities across multiple countries and manufacturing sites. Partners with operations, quality, finance, commercial, and IT to improve supply continuity, working capital, supplier performance, operational resilience, and customer service. Develops global leaders, drives transformation, and provides executive visibility into supply chain risks and performance.

Leads engineering strategy across program management, manufacturing engineering, process development, and operational excellence for regulated medical devices. Oversees NPI, injection molding, extrusion, electromechanical assembly, process validation, technology transfer, Lean and Six Sigma improvement, quality systems, capital planning, and global engineering teams. Requires deep medical device manufacturing expertise, regulatory knowledge, talent development, and executive-level leadership. Global travel is required, estimated up to 30%.

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.

Serves as the senior technical authority for catheter and balloon catheter manufacturing processes. Leads process development, design transfer, validation, tooling and equipment qualification, root-cause investigations, CAPA, and continuous improvement. Develops procedures and validation protocols while ensuring FDA and ISO compliance. Manages ERP manufacturing data, partners with Quality, Regulatory, R&D, and suppliers, and mentors engineering and production personnel. Requires deep hands-on expertise in balloon forming, extrusion, tipping, bonding, welding, assembly, and medical device manufacturing.

Leads medical device manufacturing process development, validation, optimization, and continuous improvement. Develops engineering protocols, validation reports, bills of materials, work instructions, and SOPs compliant with FDA regulations and ISO 13485. Designs fixtures, tooling, and production equipment; troubleshoots processes; leads root cause analysis and CAPA activities; and collaborates with Quality, R&D, and Production teams to support product launches and improve quality, efficiency, and waste reduction.

Owns the lifecycle of manufacturing equipment, fixtures, tooling, and inspection systems. Responsibilities include equipment documentation, preventive maintenance programs, metrology equipment specification and qualification, validation support, Gage R&R studies, sustaining backlog management, and root-cause investigations. The role partners with technicians, Quality, vendors, and Manufacturing Engineering in a regulated manufacturing environment, supporting medical-device equipment and process controls.

Leads manufacturing engineering for medical device commercial production, including new product introduction, process transfer, validation, automation, equipment qualification, tooling, sustaining engineering, and continuous improvement. Supervises engineering staff, manages KPIs and capital projects, supports troubleshooting and CAPA investigations, and ensures compliance with 21 CFR Part 820, ISO 13485, GDP, EHS policies, and customer requirements.

Lead manufacturing engineering activities for medical device products, including design and BOM reviews, process development, equipment qualification, validation, testing, documentation, and engineering-to-manufacturing transfers. Collaborate with customers, quality, supply chain, product development, internal manufacturing teams, and outsourced partners to address quality and cost issues, establish production metrics, ensure QSR compliance, and support multiple production lines and projects.

Supports the HR team with recruitment, interview scheduling, onboarding, employer branding, bilingual internal communications, HR events, people analytics, reporting, recordkeeping, calendar coordination, data entry, and administrative tasks. The intern will gain broad HR experience across operational and administrative employee populations in a regulated manufacturing environment.

The Senior Software Engineer develops and maintains software/firmware for innovative medical technologies, collaborating with teams, mentoring junior engineers, and ensuring quality through documentation and testing.

Develops and maintains capacity-balanced master production schedules across medical device client programs. Converts forecasts and orders into executable ERP/MRP plans, manages work orders, capacity constraints, materials, inventory, and planning master data. Coordinates with manufacturing, procurement, quality, program management, and clients to protect delivery commitments. Supports S&OP, dashboards, scenario planning, continuous improvement, and compliance with medical device quality and regulatory requirements.

Responsible for managing cross-functional activities in new product development, tracking schedules and budgets, coordinating with stakeholders, and ensuring compliance with ISO 13485 standards.