Jobs at Tegra Medical

Develops and scales manufacturing processes for complex medical devices, from project scoping and quoting through production launch. Responsibilities include schedule management, design-for-manufacturing collaboration, fabrication and assembly development, work instructions, training, inspection methods, process validation, quality documentation, and production-floor implementation. Works closely with customers, Quality, Operations, and project teams to meet milestones and improve cost and product quality.

Lead engineering and manufacturing projects from initiation through closure. Responsibilities include project planning, scheduling, milestone tracking, cross-functional coordination, supplier management, root-cause and corrective-action initiatives, validation and equipment qualification support, status reporting, risk escalation, and production-readiness implementation in a regulated manufacturing environment.

Participate in a three-year, 6,000-hour certified machinist apprenticeship while learning to set up, operate, and program CNC Swiss lathes, CNC lathes, milling machines, and manual equipment. Read specifications and blueprints, adjust tooling, monitor machine performance, inspect parts using precision measurement tools, perform secondary operations, and meet quality requirements. Complete mandatory online manufacturing coursework and follow safety, PPE, production, and procedural standards.

Serves as the primary customer liaison for manufacturing, quality, engineering, sales, and supply chain teams. Manages purchase orders, shipment dates, customer portals, order changes, complaints, quotations, pricing updates, open orders, and customer inquiries. Resolves issues, coordinates production schedules, supports customer service and accounts payable, provides technical guidance, and maintains customer records and job documentation.

Manages broad HR functions including full-cycle recruiting, onboarding, immigration and expatriate support, benefits, payroll, leave management, employee relations, training, recognition programs, compliance, and disciplinary reviews. Maintains HR systems and salary matrices, mentors leaders, supports employee development, and contributes to HR initiatives. Requires independent decision-making, strong communication and organization, legal knowledge, and up to 25% travel.

Operate manual and CNC/NC Swiss, milling, lathe, and EDM machines to manufacture production and prototype components. Perform machine setups, offsets, tool changes, inspections, measurements, testing, deburring, and machine operation support. Follow quality-system, customer, safety, environmental, and work-area procedures while maintaining product tolerances. Assist with preventive maintenance and complete additional assignments as directed.

Leads quality and process engineering activities in a medical device manufacturing environment. Develops quality systems and ensures FDA QSR, GMP, and ISO 13485 compliance; investigates failures, complaints, nonconformances, and CAPA; manages supplier changes; leads IQ, OQ, PQ, and PPQ validation activities; analyzes quality metrics; defines inspection requirements; performs risk analysis; and drives root-cause resolution and continuous improvement.

Supervise Quality Assurance and Document Control teams while maintaining medical device quality systems compliant with ISO 13485, FDA QSR, GMP, and GDP requirements. Manage quality records, documentation, audits, regulatory requests, reporting, staff development, and process improvements. Support daily QA and document control activities within a manufacturing environment.

Serves as the primary customer liaison, managing purchase orders, quotes, shipment dates, customer portals, order changes, complaints, and open orders. Coordinates customer needs across sales, supply chain, manufacturing, quality, and engineering; resolves issues, supports invoicing inquiries, handles calls, and provides technical guidance. The role also assists with customer service coverage, order entry, job launches, and switchboard duties.

Develops, implements, and sustains manufacturing processes, equipment, tooling, fixtures, and technical methods for medical-device components. Provides hands-on production support, troubleshoots quality and equipment issues, leads root-cause investigations and process improvements, and supports new-product introduction, production transfers, equipment qualification, process validation, CAPA, and quality documentation. The role works cross-functionally with Operations, Quality, Maintenance, NPI, Automation, Supply Chain, and suppliers.

Designs, implements, evaluates, and improves manufacturing processes, equipment, layouts, tooling, fixturing, and quality systems. Ensures cost efficiency, safety, regulatory compliance, and product quality while troubleshooting machinery and supporting design for manufacturability. The role uses CNC, CAD, CAM, data analysis, and ERP systems, collaborates with customers and teams, documents activities, and may lead improvement initiatives.