Jobs at Nextern

The Senior Quality Assurance Engineer ensures operational quality in manufacturing, supports audits, manages nonconformances, and oversees compliance with quality systems and regulations.

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.

Lead local budgeting, forecasting, and long-range planning for manufacturing. Maintain financial models, analyze variances and KPIs, support monthly and ad-hoc reporting, partner with operations and global finance, improve reporting automation, and participate in ERP and reporting projects.

Lead design, development, and sustaining engineering for catheter-based medical devices. Perform hands-on prototyping, testing, process and test method validation, manufacturing process development, DFM, and DHF documentation. Collaborate with Operations, Quality, and Manufacturing Engineering to scale production, support CAPA/root-cause investigations, and mentor junior engineers through product lifecycle to commercialization.

The Production Supervisor oversees production operations, resolves technical issues, implements Lean methodologies, and ensures compliance with safety and quality standards while managing staff performance and communication.

The Principal Electrical Engineer will lead design and testing of electronic systems for medical devices, mentor junior engineers, and engage with clients to ensure product compliance and excellence.

Lead US CDMO site operations with P&L accountability. Design scalable organization, drive operational excellence (KPIs, lean), enable NPI-to-commercial scale, ensure regulatory compliance (FDA, ISO), manage budget/capex, and align cross-functional teams to meet client commitments.

Plan, design and optimize production processes for medical device manufacturing. Manage equipment evaluation and implementation, run process simulations, perform validation and risk assessments, develop documentation, quality criteria and safety guidelines, and oversee start-up and certification while managing costs, schedules, and multiple projects.

The OPEX Engineer will lead continuous improvement initiatives using Lean and Six Sigma methodologies, collaborating with cross-functional teams to enhance manufacturing and production efficiencies while ensuring compliance with quality standards.

Lead and execute quality engineering activities for manufacturing and new product transfers in a regulated environment. Perform validations, audits, process improvements, and inspection development. Provide floor support during production ramp-up, prepare technical reports, and mentor junior engineers. Must have hands-on shop-floor experience and catheter product expertise.

Hands-on manufacturing engineer responsible for implementing and validating manufacturing processes, generating qualification/validation documentation (IQ/OQ/PQ), working with supply chain and quality to ensure QSR compliance, supporting customer interactions, managing multiple production lines, and transferring projects from engineering to manufacturing while driving process repeatability and performance metrics.

Create and maintain production plans across lines and projects to meet customer demand, ensure component availability and quality reviews, maintain ERP data (Epicor), coordinate with production and purchasing, generate reporting, support expedited orders, and enforce manufacturing best practices and training.

Own strategic direction, financial performance, and long-term growth for multi-million dollar strategic accounts. Build executive-level relationships, manage contracts and forecasts, lead cross-functional teams across NPD and sustaining operations, run strategic business reviews, identify and mitigate program risks, and drive account expansion and customer satisfaction.

Lead cross-functional new product development for medical devices from concept through phase-gate development and commercialization. Manage schedules, budgets, BOM/pricing, supplier coordination, testing, process validation, documentation (Design History File), and stakeholder communication to ensure compliant, high-quality, cost-effective products.

The Quality Systems Manager oversees the Quality Management System, ensuring compliance and managing quality initiatives across Nextern US sites.

Lead onboarding, training needs analysis, and implementation of annual training plans; supervise administrative services (reception, facilities, meals, transport); manage expat/visitor logistics (visas, permits, travel); maintain HRIS attendance and employment status; coordinate employee engagement and welfare events; liaise with government agencies and external HR service providers; support policy design and other HR/Admin duties as assigned.

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