What are the responsibilities and job description for the Principal Mechanical Design Engineer position at RxFunction, Inc.?
Description
Position Summary
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.
Job Responsibilities
Position Summary
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.
Job 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
- 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
- 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
- The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.