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Develop and maintain embedded software and firmware for regulated medical devices. Responsibilities include architecture, coding, documentation, integration and unit testing, defect resolution, risk analysis, configuration and release management, and verification support. The engineer will participate in technical reviews, improve software processes, act as a product owner or subject matter expert, and mentor junior engineers.

Leads the design, development, testing, and documentation of complex electrical and electronic systems for medical devices. Collaborates with multidisciplinary teams and clients, defines requirements, resolves technical issues, performs root-cause analysis, supports regulatory compliance, and mentors junior engineers. The role requires expertise in analog and digital circuitry, hardware design, testing, debugging, and embedded firmware development.

Serves as the senior technical authority for catheter and balloon catheter manufacturing processes. Leads process development, design transfer, validation, tooling and equipment qualification, root-cause investigations, CAPA, and continuous improvement. Develops procedures and validation protocols while ensuring FDA and ISO compliance. Manages ERP manufacturing data, partners with Quality, Regulatory, R&D, and suppliers, and mentors engineering and production personnel. Requires deep hands-on expertise in balloon forming, extrusion, tipping, bonding, welding, assembly, and medical device manufacturing.

Leads medical device manufacturing process development, validation, optimization, and continuous improvement. Develops engineering protocols, validation reports, bills of materials, work instructions, and SOPs compliant with FDA regulations and ISO 13485. Designs fixtures, tooling, and production equipment; troubleshoots processes; leads root cause analysis and CAPA activities; and collaborates with Quality, R&D, and Production teams to support product launches and improve quality, efficiency, and waste reduction.

Supervise procurement activities, supplier relationships, negotiations, cost management, delivery schedules, quotations, purchase orders, invoices, and payment reconciliation. Coordinate with Quality, Engineering, Planning, Production, and Finance teams to resolve supplier and production issues. Ensure suppliers meet cost, quality, and delivery requirements while providing accurate updates to management and corporate stakeholders.

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.

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 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.