Jobs at Forj Medical

Leads engineering and new product introduction projects from feasibility through validated production at a medical-device injection-molding site. Coordinates tooling, process, equipment, quality, validation, documentation, suppliers, and cross-functional teams. Responsibilities include DFM reviews, mold trials, engineering builds, capability studies, risk management, technical documentation, customer communication, quotations, continuous improvement, and manufacturing handoff. Ensures compliance with quality systems, customer requirements, and applicable regulatory standards.

Leads mechanical and electromechanical medical device development from concept through commercialization, including requirements, design, prototyping, verification and validation, documentation, risk analysis, and production-intent builds. Collaborates with Quality, Regulatory, Manufacturing, Supply Chain, Clinical, and Program Management teams to ensure compliance and launch readiness. The role independently resolves complex technical issues, supports FDA submissions, and applies design controls, CAD, GD&T, DFx, materials, and manufacturing expertise.

Leads medium-scale medical device development programs from proposals through commercialization. Manages customer relationships, project schedules, budgets, scope, risks, milestones, quality, and manufacturing transfer. Coordinates cross-functional teams across engineering, manufacturing, supply chain, quality, regulatory affairs, and external suppliers in a matrixed environment. Oversees multiple programs while ensuring on-time, on-budget execution and clear communication with customers and internal stakeholders.

Designs and improves injection molds, fixtures, and precision tooling for medical-device manufacturing. Creates 3D models, drawings, assemblies, and bills of materials; develops manufacturable tooling concepts; supports mold-flow and tolerance analysis, design reviews, qualification, troubleshooting, and production. Collaborates with customers, toolmakers, engineers, suppliers, quality, and operations while managing design changes, technical records, corrective actions, and continuous improvement.

Leads the engineering team and site operating model for new-product introduction at a medical-device injection-molding facility. Oversees feasibility, quoting, tooling, process development, validation, launch, and transfer to sustaining operations. Provides technical direction on molded products, molds, fixtures, automation, equipment, and secondary operations while managing customer relationships, resources, capital, suppliers, quality compliance, and cross-functional execution. Develops team capability, performance metrics, scalable systems, and production-readiness practices for complex contract-manufacturing programs.

Build and lead the medical device manufacturing transfer program, overseeing production line and site transfers, decommissioning, schedules, budgets, risks, validation support, training, ramp-up, and stabilization. Coordinate cross-functional and international teams, especially with the Costa Rica facility, while establishing governance, tools, templates, and processes. Report status and recommendations to leadership, align plans with customer commitments, and scale the transfer function over time.

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.

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.

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.

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.

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.

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.

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.

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.