Jobs at Integer Holdings Corporation

Develops and improves medical device products and manufacturing processes from concept through commercialization. Responsibilities include engineering design, tooling, process-flow planning, testing, failure analysis, root-cause investigation, technical documentation, quality-system compliance, and continuous improvement. The role independently manages moderate-complexity projects, collaborates cross-functionally, supports manufacturing excellence initiatives, and applies engineering and data-analysis techniques to improve quality, efficiency, and process capability.

Operate and monitor CNC Swiss lathe screw machines producing precision medical device components. Responsibilities include machine setup, calibration, material loading, finishing operations, blueprint interpretation, visual and dimensional inspection, documentation, cleaning, and routine maintenance while following safety and quality requirements.

Owns and governs a global quality management subprocess across multiple sites. Defines standards, manages process performance and corrective actions, ensures FDA, EU MDR, and ISO 13485 compliance, supports audits, leads digital workflow improvements, and drives continuous improvement. The role requires cross-functional leadership, stakeholder engagement, process analytics, enterprise transformation, and global rollout management in a medical device manufacturing environment.

Leads commercial finance for product lines, including revenue planning, sales budgets, rolling forecasts, pricing, quoting, business case modeling, and commercial decision support. Develops analytics on rebates, pricing, sales trends, backlog, and revenue performance. Partners with Commercial, Growth, Operations, Applications Engineering, and executive stakeholders while implementing enterprise finance standards and continuous improvement using ERP, CRM, Power BI, Excel, and automation tools.

Provides financial leadership and strategic support for profitable growth through budgeting, forecasting, financial reporting, operational analysis, and business planning. Partners with business leaders on P&L, balance sheet, capital investments, cost management, cash flow, and performance improvement. Leads monthly reporting, forecast accuracy initiatives, financial modeling, continuous improvement, and lean manufacturing finance activities. Requires manufacturing finance expertise across multiple facilities and may manage staff.

Performs engineering work supporting medical device manufacturing, including product and process improvement, failure analysis, root-cause investigation, quality documentation, and moderate-complexity project execution. Plans and executes engineering activities, evaluates materials and processes, supports corrective and preventive actions, applies data analysis, and promotes continuous improvement through manufacturing excellence, standardization, problem solving, and process optimization.

Performs entry-level engineering work supporting manufacturing projects, product and process improvements, failure analysis, root-cause investigations, quality initiatives, and continuous improvement. Supports strategic projects involving new products, equipment, materials, procurement, installation, commissioning, qualification, budgeting, scheduling, vendor coordination, and CAR documentation. Collaborates with cross-functional teams while following safety, environmental, security, quality, FDA, and production system requirements.

Supervise and develop a team of engineers and technicians supporting manufacturing product lines. Drive safety, quality, delivery, cost improvement and continuous improvement using lean methods, audits, and training. Coordinate cross-functional resources, ensure QMS compliance, and support new product and technology deployments.

Provide strategic technical leadership for manufacturing and process development across product lifecycles. Lead continuous improvement, design reviews, quality (QMS/FDA) adherence, and mentor engineers. Drive Manufacturing Excellence (5S, SiOP, VSM, TPM), support customer interactions and supplier improvements, manage project schedules/budgets, and deliver cost, productivity, and quality improvements.

Lead the strategy, governance, validation, adoption, and sustainment of quality technologies in an FDA-regulated medical device environment. Oversee QMS, MES, LMS, software assurance, data integrity, electronic records, CSA, audit readiness, and digital quality transformation. Build business cases, define roadmaps and requirements, guide regulatory risk management, and partner across Quality, IT, Operations, Engineering, Regulatory, and site leadership. Lead and develop a global team while driving compliant, user-focused technology adoption and continuous improvement.

Manages multiple engineering and product development projects from initiation through implementation, overseeing budgets, schedules, forecasts, milestones, scope, risks, quality, and customer commitments. Leads cross-functional teams, coordinates with engineering, manufacturing, quality, regulatory, marketing, suppliers, and customers, and serves as the escalation point. Supports quoting and commercial opportunities, improves PMO processes, applies product and manufacturing development systems, and mentors team members. The role may supervise engineers or technicians and requires domestic and international travel up to 30%.

Performs quality engineering for medical device manufacturing, including audit and inspection support, manufacturing compliance, document and BOM review, test method validation, process capability studies, inspection procedure development, nonconforming material disposition, complaint investigations, CAPA, root-cause analysis, internal audits, and continuous improvement. Collaborates with manufacturing and cross-functional teams while supporting regulatory requirements, quality metrics, product transfers, and manufacturing excellence initiatives.

Set up, operate, troubleshoot, and maintain CNC equipment to manufacture precision parts. Adjust tooling and offsets, monitor tolerances, inspect components using microscopes and measurement tools, complete quality documentation, perform preventative maintenance, and follow safety, FDA, QMS, and lean manufacturing requirements. The role also supports continuous improvement and requires cross-training in a first-shift Monday-through-Thursday schedule.

Plans and maintains production schedules based on orders, resources, materials, equipment, and workforce availability. Coordinates with production, procurement, logistics, and other teams to resolve scheduling conflicts, minimize interruptions, maintain inventory targets, and support on-time delivery. Maintains production parameters in ERP systems, monitors production status and inventory levels, recommends schedule changes, and reports issues to supply chain leadership while following quality, safety, environmental, security, FDA, and company requirements.

Supports enterprise demand planning and the monthly SIOP process by maintaining statistical and consensus forecasts, analyzing forecast accuracy and planning KPIs, identifying demand risks and opportunities, and improving inventory and customer service outcomes. Serves as a demand planning system subject matter expert, supports implementations and change management, and collaborates with Customer Operations, Supply Planning, Finance, Sales, and Supply Chain teams across manufacturing sites.

The Post Market Surveillance Engineer II supports complaint handling, regulatory reporting, and product investigations for medical devices, ensuring compliance with regulations and quality management systems.

Coordinates production schedules, determines staffing, equipment, and material requirements, and manages plans using demand forecasts, capacity, and available resources. Monitors inventory, lead times, bottlenecks, and capacity utilization while adjusting schedules to meet production goals. Generates performance reports, maintains production plans in ERP systems, and collaborates with cross-functional teams while following quality, safety, environmental, security, and regulatory requirements.

Executes complaint handling, regulatory reporting, post-market surveillance, product investigations, risk assessments, CAPA support, adverse-event reportability assessments, and audit support for medical devices. Documents complaints, reviews device records, coordinates investigations, communicates with customers, supports regulatory submissions and post-market trending, and contributes to quality-system improvements, manufacturing excellence, and quality KPI achievement while following FDA and international requirements.

Drives manufacturing excellence across global facilities by deploying the Integer Production System, leading Hoshin Planning and transformation initiatives, facilitating lean improvement workshops, coaching site leaders, promoting lean culture, and managing direct reports. The role focuses on improving safety, quality, delivery, lead time, cost, inventory, employee engagement, and sustainable operational performance, with travel varying from 25% to 75%.

Supports production operations as the primary technical resource for manufacturing lines. Develops and implements process, equipment, tooling, and fixture solutions to improve safety, quality, delivery, and cost. Maintains manufacturing documents and digital operations systems, leads equipment qualification and process validation, performs root-cause analysis, and executes corrective and preventive actions. Collaborates cross-functionally on design for manufacturability, continuous improvement, quality, and moderate-complexity product and process technology projects.