Principal NPI Manufacturing Engineer, Electromechanical Systems

Job Description:

POSITION SUMMARY The Principal NPI Manufacturing Engineer, Electromechanical Systems serves as the technical project leader for NPI manufacturing activities, driving the development, design transfer, manufacturing readiness, and commercialization of Trans Medics OCS products.

This role will have a particular focus on integrated electromechanical equipment incorporating mechanical, electrical/electronic, and software-controlled components. The Principal Engineer will provide technical leadership across new product introduction activities involving capital medical equipment, consoles, diagnostic or imaging systems, and other complex electromechanical devices while ensuring robust, scalable, compliant, and manufacturable product designs and processes.

RESPONSIBILITIES This position is responsible for, but not limited to, the following:

Provide strategic oversight of manufacturing readiness for new product introductions, ensuring alignment of engineering resources, project schedules, technical requirements, and cross-functional deliverables.

Serve as a technical leader for the manufacturing introduction and commercialization of complex medical equipment incorporating mechanical, electrical/electronic, and software-controlled components.

Lead cross-functional collaboration with Product Development, Quality, Regulatory, Supply Chain, Manufacturing Operations, and other engineering teams to ensure robust, scalable, and compliant manufacturing processes.

Coordinate, identify, develop, and implement advanced manufacturing processes to ensure production capacity, efficiency, cost-effectiveness, product quality, and adherence to applicable regulatory requirements.

Define project plans, timelines, technical work streams, and resources required to support NPI manufacturing programs, ensuring accountability for milestones and deliverables.

Apply in-depth technical expertise to specify, design, develop, qualify, and validate manufacturing equipment, tooling, fixtures, automation, and manufacturing test equipment.

Drive Design for Manufacturing and Assembly (DFM/DFA), PFMEA, Design Transfer, process development, and manufacturing validation activities to establish capable, efficient, and risk-mitigated manufacturing processes.

Develop manufacturing assembly and functional test methods that ensure Critical to Quality (CTQ) and Critical to Assembly (CTA) requirements are met.

Provide manufacturing engineering expertise related to PCB/PCA assemblies, electrical and electronic components, wiring and cabling, sensors, motors and pumps, displays/HMIs, and hardware/software interfaces.

Lead and support system-level troubleshooting, root-cause and failure analysis, functional testing, manufacturing test equipment development, calibration activities, and hardware reliability assessments during new product introduction and manufacturing scale-up.

Develop and optimize manufacturing processes for integrated electromechanical assemblies, subassemblies, and final system-level builds.

Establish and track Key Performance Indicators (KPIs) and process capability metrics using statistical tools and methodologies such as MSA, GR&R, SPC, and related process capability techniques.

Represent Trans Medics internally and externally as a manufacturing subject matter expert (SME), ensuring effective technical communication and knowledge transfer to production teams, suppliers, and cross-functional stakeholders.

Provide day-to-day technical leadership and direction across assigned NPI work streams.

Mentor and guide junior engineers and technical staff, fostering a culture of engineering rigor, accountability, problem solving, and innovation.

Perform other Trans Medics tasks and duties as required.

PHYSICAL ATTRIBUTES Office and…