Jobs at Lexington Medical

Own and improve the Arena electronic Quality Management System, ensuring compliance with ISO 13485, FDA QMSR, 21 CFR Part 11, MDSAP, and EU MDR. Manage document control, CAPA, nonconformance, training, audits, supplier quality, risk management, metrics, and computer system validation. Prepare the organization for certification and regulatory audits while partnering with Operations, Engineering, Regulatory, and Manufacturing to drive quality improvements.

Leads a team of mechanical and product engineers developing surgical stapling instruments from concept through production and sustaining changes. Owns design controls, Design History Files, design transfer, technical project execution, design reviews, root cause analysis, and cross-functional collaboration with manufacturing, quality, regulatory, supply chain, and commercial teams. Manages hiring, development, performance, project planning, and delivery for regulated medical device products.

Develop, test, and debug embedded firmware for surgical stapling devices using C and C++ on ARM Cortex-M microcontrollers. Build drivers, communication interfaces, motor-control logic, and sensor integrations. Collaborate with electrical, mechanical, and systems engineers during hardware bring-up and bench debugging. Support verification, validation, code reviews, and documentation compliant with FDA design controls and IEC 62304.

Design and develop embedded electrical systems for powered surgical stapling devices. Responsibilities include schematic capture, PCB design, component selection, mixed-signal and microcontroller-based circuit development, hardware bring-up, debugging, testing, system integration, verification, validation, and regulated design documentation. The role collaborates with firmware, mechanical, manufacturing, and quality teams and supports troubleshooting and design updates for fielded medical devices.

Mechanical Engineering Intern supporting medical device product development and manufacturing. Responsibilities include engineering testing, documentation, product and process improvements, component drawings, quality inspections, equipment operation, preventative maintenance, and supply chain engineering support. The role is fully onsite and provides hands-on exposure to medical device design, manufacturing processes, regulatory standards, and engineering documentation.

Supports engineering activities on an operational manufacturing line, including addressing yield and quality concerns, repairing custom production equipment, and assisting with training. Evaluates processes for bottlenecks, proposes and implements improvements, and supports equipment commissioning and line changes. Completes a manufacturing fixture design project involving requirements, design reviews, risk identification, construction, and implementation under established procedures.

Supports surgical medical device territory growth by assisting with account development, surgeon and theatre staff relationships, procedure support, product trials, prospecting, case preparation, consignment stock management, and customer feedback. This field-based apprenticeship role covers Melbourne and includes regular territory travel, periodic overnight travel, and possible after-hours surgical case support, with a pathway to Territory Manager.

Supports surgical medical device territory growth by assisting with customer engagement, procedure support, product trials, prospecting, account strategy, case preparation, and consignment inventory management. Builds relationships with surgeons, theatre staff, and hospital personnel while communicating customer feedback to cross-functional teams. This field-based apprenticeship role covers Sydney and includes regular territory travel, driving, occasional overnight stays, and potential after-hours surgical case support.

Design, build, and maintain real-time embedded software for a surgical stapling platform. Lead architecture, write low-level drivers and application logic, perform hardware-software integration and bench-level debugging, establish IEC 62304-aligned processes, mentor engineers, and own embedded software deliverables through verification and product lifecycle support.

Lead and mentor a small manufacturing engineering team to optimize proprietary automation, support NPI, perform hands-on root cause analysis, manage change control, and drive continuous improvement to maintain product quality and yield in onsite medical device production.