Jobs at KLS Martin LP

Leads medical device complaint management, post-market surveillance, adverse event reporting, field actions, recalls, and regulatory compliance. Oversees reportability assessments, investigations, escalations, inspection readiness, backlog reduction, process improvement, dashboards, and cross-functional risk management. Manages complaint personnel, partners with Legal and Regulatory teams, and ensures compliance with FDA, ISO 13485, MDSAP, and global vigilance requirements.

Performs machine software preparation, additive manufacturing build orientation, defect monitoring, tensile testing, equipment troubleshooting, lot changes, and manufacturing process improvements. Supports root-cause analysis, CAPA and complaint investigations, documentation, new product development, and production engineering initiatives. The role requires maintaining process-controlled equipment and ensuring timely production of mechanically stable parts.

Leads the IT project management function, including team leadership, portfolio intake, prioritization, capacity planning, governance, reporting, and delivery standards. Personally manages high-priority initiatives while coaching project managers and advancing PM methodology, tooling, and organizational maturity. Partners with IT, business, vendors, Quality, and Regulatory stakeholders to manage risks, budgets, benefits, compliance, audits, and regulated systems delivery. Promotes AI adoption across the team and supports expansion of project management practices beyond IT.

Owns accounting, reconciliation, reporting, and financial controls for payroll, benefits, compensation, and other employee-related costs. The role connects HR, payroll, and financial systems; supports month-end close, workforce planning, budgeting, forecasting, variance analysis, audits, and data integrity. It also partners cross-functionally to resolve discrepancies, improve processes, and strengthen reporting and controls.

Supervises daily accounting operations, coordinates financial close activities, reviews journal entries and reconciliations, supports internal controls and compliance, and prepares financial reporting. Provides team direction, coaching, and quality review while assisting with audits, tax reporting, system updates, process improvement, and cross-functional accounting issue resolution.

Manage medical product lines as business units by developing marketing and launch plans, supporting sales and clinical education, gathering customer insights, coordinating product improvements, and assisting with regulatory documentation. The role includes field travel to trade shows, hospitals, workshops, cadaver labs, and surgeries; training employees and customers; analyzing markets and competitors; managing inventory and product requests; and mentoring Product Specialists.

Supports the IPS data coordination team by learning the Individual Patient Solution workflow, maintaining patient case files, retrieving and verifying documentation, and assisting with projects involving process improvement, educational materials, product design and testing, and quality assurance. Coordinates with production, sales, marketing, product management, and engineering teams while following regulatory, quality, and safety procedures.

Supports the Meetings Team by responding to sales requests, providing product information, gathering and packing meeting products, verifying returned materials, assembling and shipping display booths, and ordering supplies. Maintains records, verifies information, manages multiple priorities, and uses SAP and Microsoft Office. The role requires communication, organization, problem-solving, and the ability to lift and handle meeting materials.

Supports experienced engineers with Individual Patient Solution workflows, process improvement, educational materials, product design and testing, quality assurance, and case documentation. Collaborates with production, sales, marketing, and product management while following regulatory and internal guidelines. The intern shadows operations, assists with IPS cases, develops problem-solving and communication skills, and gains practical engineering experience in medical device product development.

Supports and improves the medical-device Quality Management System by leading QMS processes, audits, CAPA, nonconformity investigations, document control, supplier and calibration oversight, recalls, management reviews, and quality data analysis. Ensures compliance with FDA, ISO 13485, MDSAP, and international requirements while coordinating cross-functional improvements and providing technical guidance to junior team members.

Analyzes and redesigns processes across manufacturing, supply chain, warehousing, logistics, and fulfillment. Applies Lean principles, data analysis, capacity analysis, root cause analysis, and process engineering to improve efficiency, quality, throughput, inventory, and cost. Develops standardized workflows, KPIs, dashboards, automation, and system improvements while partnering cross-functionally with Operations, IT, Quality, Finance, and Supply Chain teams. Manages continuous improvement initiatives through implementation and ongoing monitoring.

Supports Individual Patient Solution case administration by creating sales and production orders in SAP, coordinating checklists, assembling Device History Records, preparing invoices, verifying documentation in IPS Gate, and delivering production packets. The role communicates with Manufacturing and Engineering, manages department correspondence, performs office administration, and maintains accurate, compliant, audit-ready records and workspaces in a time-sensitive medical-device production environment.

Manages contract administration, pricing operations, customer agreements, bid and RFP responses, contract renewals, pricing analytics, and compliance reporting, including Open Payments and state transparency submissions. Provides pricing and contract guidance to Sales, supports negotiations, maintains contract records and reporting metrics, and supervises contract operations staff. Partners with Finance, Legal, Compliance, and Operations to ensure accurate, compliant, and efficient contracting processes.

Supports investigations of customer complaints involving individual patient solution medical devices within a regulated quality system. Duties include complaint intake, feedback review, 3D dimensional analysis of returned products, data logging, information gathering from Sales, controlled documentation, and support for Systems Engineering investigations. The role develops foundational skills for advancement to an IPS Investigation Specialist I position.

Analyze and improve SAP business processes, develop process maps, gather requirements, and recommend system solutions. Support SAP testing, troubleshooting, integrations, upgrades, automation, data integrity, reporting, and AI opportunity evaluation. Collaborate with stakeholders, manage change rollouts, document solutions, provide training, and monitor performance metrics. The role requires broad SAP module knowledge, strong analytical and communication skills, and experience working in controlled or regulated environments.

Lead design and implementation of a scalable enterprise data warehouse: dimensional modeling, ETL/ELT pipelines, cloud data platforms, data governance, performance tuning, monitoring, and mentoring. Collaborate with stakeholders and engineering teams to enable analytics, ensure data quality and security, and support data science/ML workloads including feature engineering and NLP components.

Support planning, execution, and documentation of verification and validation (V&V) activities for medical devices. Develop test protocols and reports, manage external labs, ensure ISO 10993 biocompatibility compliance, perform toxicological risk assessments, support regulatory (FDA) submissions, maintain traceability, participate in design reviews, and coordinate technology transfer and outsourced studies across cross-functional teams.

Design, develop, and maintain ABAP solutions and SAP Fiori applications. Troubleshoot and optimize ABAP code, integrate SAP with third-party systems, create OData services, conduct code reviews, mentor junior developers, and produce technical documentation to support S/4 HANA implementations and upgrades.

Lead consolidated budgeting, forecasting and long-range planning. Develop financial models, scenario analyses and executive reporting. Partner with business leaders on performance, cash flow, liquidity and capital allocation. Manage FP&A team, integrate ERP and structured data, and support treasury and decision-support analyses to drive financial discipline.

Design and develop medical device products from concept through commercialization. Create and check CAD models and drawings, apply GD&T and FEA, prepare models for 3D printing, develop prototypes, plan and execute verification/validation tests, perform root-cause and tolerance stack-up analysis, write technical protocols/reports, and collaborate across production, quality, sales, and product management while following regulatory and internal requirements.