Jobs at Nextern

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.

Support incoming inspection quality programs, monitor corrective actions, document QMS and GxP control activities, and help update supplier documentation to ensure compliance with medical device quality regulations.

Responsible for managing quality requirements, leading investigations, performing audits, and mentoring in quality practices while supporting product development and compliance.

The Senior Design Assurance Engineer ensures design quality in new product development, supports manufacturing compliance, and manages regulatory documentation while leading project teams and improving quality systems.

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.

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.

The Sr. Project Manager will lead project initiatives in the medical device sector, coordinating product development, managing timelines and budgets, ensuring regulatory compliance, and mentoring junior managers.

Supervise production staff and coordinate resources to meet KPIs and production plans. Assign stations, monitor processes and equipment, enforce quality and GMP standards, coach and develop team members, analyze production data, troubleshoot issues, and lead continuous improvement initiatives while maintaining safety and HR compliance.

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

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.

Hands-on manufacturing engineer responsible for process and equipment validations (IQ/OQ/PQ), creating equipment specs and fixture drawings, managing change control and documentation, supporting audits and regulatory compliance, training operators, coordinating tests and CAPA investigations, and collaborating with R&D, Quality, Production, and Supply Chain for new product introductions and process improvements.

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.