Jobs at Nextern

Designs, optimizes, and supports manufacturing processes for electro-mechanical and single-use medical devices. Develops procedures, tooling, fixtures, and equipment while ensuring FDA and ISO compliance. Leads root cause investigations, CAPA, process validation, continuous improvement, and production troubleshooting. Uses Epicor ERP for BOMs, routing, work orders, inventory, and planning. Collaborates with Quality, Regulatory, R&D, and Production on launches and transfers, supports design controls, and trains production personnel.

Administer and maintain global Windows and Linux infrastructure, identity platforms, Microsoft 365, virtualization, networking, endpoints, backups, and disaster recovery. Resolve escalated support issues, monitor system reliability, execute patching and upgrades, manage access controls and vendors, document systems, and support infrastructure projects. Collaborate with cybersecurity teams in a regulated medical-device manufacturing environment. Occasional domestic or international travel may be required.

Leads medical device development projects from concept through phase-gate development, pilot production, manufacturing, and commercialization. Coordinates customers, engineering, supply chain, manufacturing, and business development teams while managing schedules, budgets, resources, risks, and scope. Reviews designs, develops bills of materials and quotations, supports testing and validation, facilitates production across sites, and ensures compliant documentation, including Design History Files and regulatory submissions.

Leads medical device manufacturing operations, supervising production personnel and managing scheduling, staffing, capacity, throughput, quality, cost, and on-time delivery. Oversees production planning, product transfers, operator training, documentation, nonconformance and CAPA response, audits, and compliance with regulated manufacturing requirements. Drives continuous improvement using Lean, 5S, and Six Sigma while developing teams and executing cost-reduction initiatives.

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 quality engineering activities for manufacturing and new product transfers in a regulated environment. Execute validations, audits, and quality assessments; improve manufacturing and inspection processes; support production ramp-up on the shop floor; prepare technical reports; collaborate with cross-functional teams and customers; and mentor junior engineers. The role requires catheter experience and expertise in quality engineering, process compliance, and technical leadership.

Leads supplier quality activities for medical device materials and components, including supplier selection, qualification, audits, performance monitoring, change notifications, SCARs, testing, CAPAs, nonconformances, and quality metrics. Owns supplier-related quality system processes and supports internal and external audits. Partners across engineering, manufacturing, supply chain, and quality teams while providing technical leadership and potentially supervising employees.

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 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.

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.