Principal Mechanical Design Engineer

RxFunction•Eden Prairie, MN

About The Position

The Principal Mechanical Design Engineer is a subject matter expert within the product development team, bringing deep technical expertise in mechanical design for medical devices. This role drives innovation by applying current best practices and emerging technologies to develop robust, manufacturable solutions and differentiated intellectual property. This is a high-impact, hands-on technical leadership role at the core of our product innovation. You will help define the next generation of our medical devices while strengthening the mechanical design foundation needed to support a growing product portfolio. You will play a critical role in bridging early-stage innovation with scalable, reliable product development, directly influencing product architecture, performance, and engineering processes as the organization grows. You thrive in a dynamic, fast-paced environment, balancing multiple priorities while independently driving complex projects from concept through production. You play a key role in translating user and clinical needs into engineering solutions, balancing speed with the rigor required for regulated medical devices.

Requirements

Bachelor’s degree in mechanical engineering, biomedical engineering, or related field, with 7+ years of experience in medical device mechanical design and development
Demonstrated technical leadership, including experience guiding and mentoring engineers through the product development lifecycle
Strong hands-on experience with prototyping and rapid iteration (e.g., 3D printing, CNC, laser cutting) to drive early design decisions
Experience applying engineering analysis and testing methods (e.g., FEA, fatigue testing, environmental conditioning, mechanical characterization) to validate designs
Ability to translate user needs and product requirements into mechanical system architecture and detailed designs
Experience designing for manufacturability, including working with suppliers and supporting design transfer
Demonstrated ability to collaborate effectively in a fast-paced, cross-functional environment while managing multiple competing tasks and demands
Demonstrated initiative, accountability, and ability to overcome technical challenges

Nice To Haves

Master’s degree or higher in Mechanical Engineering or related field
Experience designing and commercializing medical devices in a regulated environment
Knowledge of applicable standards and regulations for medical device mechanical design
Expertise in manufacturing processes such as injection molding, CNC machining, and assembly design
Experience generating detailed engineering drawings, specifications, and tolerance analyses
Familiarity with statistical methods and their application to design and validation

Responsibilities

Drive key mechanical architecture decisions that impact current and future product platforms
Lead mechanical design efforts across the full product lifecycle, from concept through launch and sustaining support
Translate user needs, clinical insights, and product requirements into robust system-level design solutions
Design, prototype, and evaluate concepts to rapidly de-risk and mature product architectures
Apply engineering analysis (analytical, simulation, and empirical testing) to ensure designs meet functional and reliability requirements
Evaluate materials, technologies, and manufacturing processes with consideration for durability, scalability, and cost
Define and implement mechanical design best practices, including design for manufacturability and reliability
Partner with Operations and suppliers to support design transfer, manufacturing readiness, and production scaling
Develop and maintain design control documentation (user needs, design inputs, verification/validation, DHF artifacts)
Mentor engineers and elevate technical standards across the team
Collaborate cross-functionally (electrical, firmware, software, quality, manufacturing) to deliver integrated product solutions
Other duties as assigned