Jobs at Forj Medical

Manages sourcing and procurement for PCBA and assigned product categories. Responsibilities include demand analysis, purchase order management, supplier selection, contract and cost negotiations, supplier relationship and risk management, cost-reduction roadmaps, new product introduction support, BOM analysis, supplier audits, and lean process improvement. The role serves as a cross-functional liaison among procurement, program management, customers, engineering, quality, production, and suppliers.

Leads cross-functional programs involving production line, manufacturing, and site transfers, including international transitions. Oversees schedules, budgets, risks, documentation, validation, training, ramp readiness, stakeholder communication, and post-transfer stabilization while coordinating engineering, quality, regulatory, supply chain, facilities, and other teams.

Own sustaining engineering and manufacturing support for assigned medical device product lines. Lead root-cause investigations, yield improvement, production troubleshooting, product transfers, technical documentation, IQ/OQ validation support, and quality issue resolution. Mentor manufacturing engineers, drive Lean Six Sigma continuous improvement, support electronic test systems, and collaborate with development engineering, Quality, customers, and suppliers in a regulated ISO 13485 and FDA QSR environment.

Manufacturing Engineer II manages production builds for multiple electro-mechanical medical device product lines. Responsibilities include issue resolution, sustaining bills of materials and processes, production documentation, engineering change orders, quality coordination, new product transfer, and continuous improvement focused on scrap, yield, and labor efficiency. The role also supports production teams, works with customers, and maintains awareness of regulated medical device manufacturing requirements.

Design, prototype, test, and troubleshoot power electronics and embedded medical device systems, including AC/DC and DC/DC converters, analog and digital circuits, PCBs, magnetic components, and control systems. Lead system architecture, verification, regulatory testing, design transfer, documentation, and risk analysis. Collaborate with customers, suppliers, and cross-functional teams while mentoring engineers and technicians and supporting products from concept through production.

Leads production builds for complex electro-mechanical medical devices across multiple product lines. Manages new product introduction, design transfer, pilot builds, production layouts, technical documentation, issue resolution, quality integration, and continuous improvement initiatives. Collaborates with development and quality engineering teams, supports customer technical requests, maintains compliance with FDA QSR and ISO 13485 requirements, and mentors manufacturing engineering staff.

Manages commercial contracts and legal operations, including drafting, redlining, negotiation, administration, risk analysis, contract repository oversight, and obligation tracking. Partners with Sales, Supply Chain, Operations, HR, and leadership while coordinating outside counsel, legal spend, claims, audits, investigations, and litigation support. Maintains templates, playbooks, and approval workflows in a regulated manufacturing environment.

Designs, develops, tests, and verifies analog and digital embedded medical device electronics, including PCBs, sensor interfaces, microcontrollers, and system architectures. Leads requirements definition, design reviews, documentation, compliance testing, and project planning for complex Class II/III medical devices. Provides technical leadership, mentors engineers and technicians, supports process improvements, and interfaces with customers and business development.

Lead embedded software development for safety-critical medical devices, including requirements, architecture, implementation, testing, integration, and technical decision-making. Guide software teams through agile development, ensure compliance with FDA regulations, IEC 62304, quality systems, and cybersecurity standards, and maintain software quality through reviews and mentoring. Develop embedded Linux and microcontroller software, drivers, and communication interfaces while contributing to estimates, client discussions, process improvements, and internal libraries.

Processes supplier invoices, maintains vendor banking data, prepares payment runs, resolves discrepancies, supports month-end close, records accruals, performs reconciliations, assists with audits, and provides accounts receivable support including invoicing, cash applications, and collections.

Leads architecture, technical decisions, implementation, integration, testing, and quality for safety-critical embedded medical-device software. Mentors engineers, manages technical risks, defines requirements, guides agile feature development, resolves complex system issues, and improves reusable platforms and engineering processes. Requires deep embedded Linux, Yocto, RTOS, device-driver, hardware integration, and regulated medical-device software expertise.

Develops and executes verification strategies and test procedures for medical devices, including GUI, black-box, environmental, functional, hardware, and fault-simulation testing. Maintains test plans, reports, fixture validation documentation, and regression testing. Analyzes requirements, test data, anomalies, and failures; coordinates fixture development; evaluates third-party results; supports process improvements and training. Work requires interpreting engineering requirements, using laboratory equipment, reading schematics, and applying medical device testing standards.