Job Type
Full-time
Description
The Principal Mechanical Engineer will provide technical leadership for the design and development of next-generation hemodialysis subsystems, electromechanical assemblies, and disposable components. This role will lead projects from concept and requirements definition through detailed design, verification, and introduction into manufacturing.
The Principal Mechanical Engineer is expected to be both a technical leader and hands-on engineer. The successful candidate will personally contribute to mechanical design while providing technical direction to internal engineers, cross-functional teams, and external development partners. This individual will work closely with Systems, Electrical, Software, Manufacturing, Quality, Regulatory, Clinical, and other functions to develop robust, manufacturable, cost-effective products.
Key responsibilities include defining mechanical architectures, selecting and integrating electromechanical components, designing components for machining and injection molding, developing functional prototypes, conducting design and tolerance analysis, and developing costed bills of materials. The role will also provide technical leadership for development of disposable blood-handling components and tubing sets, including design, manufacturability, cost, packaging, sterilization, usability, and performance.
The ideal candidate is a highly experienced mechanical engineer who can move comfortably between system-level architecture and detailed mechanical design, solve complex technical problems, and bring products from concept through production.
Responsibilities
• Provide technical leadership for the mechanical development of medical device systems, subsystems, assemblies, and disposable components from concept through production.
• Lead mechanical architecture and design activities, translating system requirements into robust mechanical solutions.
• Serve as the mechanical technical lead for major development programs and workstreams, establishing technical objectives, priorities, schedules, and deliverables.
• Personally perform hands-on engineering work, including mechanical design, CAD, prototyping, analysis, testing, and design optimization.
• Direct and mentor internal engineers and provide technical direction to external engineering and supplier resources.
• Lead cross-functional development activities with Systems, Electrical, Software, Manufacturing, Quality, Regulatory, Clinical, and other stakeholders.
• Develop and evaluate mechanical concepts, prototypes, and proof-of-principle designs to rapidly resolve technical uncertainty.
• Design components and assemblies for injection molding, machining, and other manufacturing processes, with a strong focus on design for manufacturability and assembly.
• Lead component and material selection, including electromechanical components, plastics, metals, seals, tubing, fittings, pumps, motors, valves, and related hardware.
• Develop and maintain mechanical requirements, specifications, design outputs, drawings, tolerance schemes, and costed bills of materials.
• Apply GD&T, tolerance analysis, FEA, and other engineering analysis methods to evaluate and optimize designs for performance, reliability, manufacturability, and cost.
• Lead mechanical verification activities, including development of test methods, protocols, fixtures, and engineering reports.
• Participate in design reviews and provide technical leadership in risk management, DFMEA, design verification, and design transfer.
• Work directly with suppliers and manufacturers to develop, troubleshoot, and qualify production-intent components and processes.
• Provide technical leadership for development of disposable blood-handling components and tubing sets, including performance, reliability, manufacturability, packaging, sterilization, and usability considerations.
• Identify opportunities to simplify designs, reduce cost, improve reliability, and accelerate development.
• Serve as a recognized mechanical engineering subject matter expert and provide technical guidance across the organization.
• Contribute to engineering standards, design practices, and continuous improvement of the organization's product development processes.
Requirements
Required Skills & Abilities
• Mechanical Engineering: Deep expertise in mechanical design and development of complex electromechanical products, preferably within a regulated medical device environment.
• Design Controls: Proven experience working within FDA design control processes, including engineering requirements/inputs, design reviews, design outputs, verification plans and protocols, risk analysis, and DFMEA.
• Injection Molding: Demonstrated experience designing and releasing production injection-molded components. Strong understanding of plastic part design, material selection, DFM/DFA, tooling, tolerancing, first article inspection, and process capability.
• Electromechanical Systems: Experience selecting and integrating pumps, motors, valves, sensors, pneumatic components, fittings, PCBs/PCBAs, and other electromechanical components into complex products.
• Mechanical Analysis: Strong knowledge of GD&T and tolerance analysis. Experience using engineering analysis tools, including FEA, for structural, fatigue, thermal, vibration, or other relevant applications.
• Prototyping: Demonstrated ability to rapidly develop functional prototypes and use experimental data to refine mechanical designs.
• Manufacturing: Experience working directly with contract manufacturers, machining suppliers, injection molders, and other manufacturing partners to develop and release production components.
• Design Optimization: Demonstrated ability to balance performance, reliability, manufacturability, cost, and schedule when making engineering decisions.
• Cross-Functional Leadership: Ability to lead technical activities across mechanical, electrical, software, systems, manufacturing, quality, and regulatory functions without relying solely on formal authority.
• Technical Communication: Excellent written and verbal communication skills, with the ability to clearly communicate complex technical issues and recommendations to both technical and non-technical audiences.
• Technical Documentation: Experience authoring engineering specifications, test plans, protocols, reports, drawings, and other design documentation in accordance with good documentation practices.
• CAD/PDM: Advanced proficiency with SolidWorks and experience with a PDM system such as PDMWorks or equivalent.
• Systems Thinking: Ability to understand interactions between mechanical, electrical, software, fluidic, and system-level requirements and make appropriate engineering tradeoffs.
Preferred Skills & Abilities
• Mechanical Architecture: Ability to develop mechanical architectures for complex electromechanical systems, decompose systems into effective subsystems, and define clear interfaces and requirements.
• Fluid Management Systems: Strong understanding of pumps, valves, tubing, connectors, filtration, pressure management, fluid pathways, and other fluid management technologies.
• Dialysis Technology: Knowledge of hemodialysis, blood handling, extracorporeal circuits, dialysis fluid preparation, or related medical technologies.
• Disposable Medical Devices: Ability to design and develop disposable blood-handling components, tubing sets, fluid pathways, and other patient-contacting or fluid-contacting components.
• Design for Manufacturing: Ability to optimize designs for injection molding, machining, assembly, tooling, and high-volume production while balancing performance, cost, and reliability.
• Reliability & Risk: Ability to identify potential failure modes and design robust, reliable products through appropriate analysis, testing, and risk mitigation.
Education & Experience
• Bachelor's degree in Mechanical Engineering or a related engineering discipline; advanced degree preferred.
• Twelve + years of relevant engineering experience, or equivalent combination of education and experience.
• Demonstrated experience serving as the technical or workstream leader for major product development programs from concept through release.
• Demonstrated history of personally contributing to successful mechanical product designs and bringing those designs into production.
• Experience in a regulated medical device environment strongly preferred.
Travel
• Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.
Physical Requirements
• Sustained periods of time standing and sitting in a laboratory
• Sitting at a desk utilizing a computer
• Some lifting of
Salary Description
$165,000 - $188,000
