Principal Mechanical Design Engineer

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

Required Qualifications

Bachelors 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

Preferred Qualifications

Masters 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

Physical Requirements:

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.

The employee is also required to use a computer and communicate with others