Staff Mechanical Engineer

Job Details

Job Location: RALEIGH - RALEIGH, NC 27615

Position Type: Full Time

Position Summary

We are seeking an exceptional Staff Mechanical Engineer to join our R&D Mechanical Engineering team and support development of novel medical devices and applications. Projects span a broad range of technologies including complex laser and optical delivery systems, high-power ultrasound, and radio-frequency devices. Our diverse technology portfolio, culture of innovation, and vertical integration provide a unique opportunity for an engineer with broad technical interests and expertise.

This position is responsible for the design and development of precision opto-mechanical assemblies, structural frames, thermal management systems, and industrial designs for advanced energy systems. The engineer will collaborate closely with Electrical, Laser, Clinical, Manufacturing, Quality, and Regulatory teams and contribute to product development from concept through product launch.

Duties & Responsibilities

• Independently model, design, and detail high-precision mechanical parts, complex sub-assemblies, and dynamic opto-mechanical systems, ensuring robust application of GD&T principles.
• Manage and structure large SolidWorks assemblies and multi-level bills of materials (BOMs) from initial concept through pilot manufacturing.
• Execute product development activities with a strong understanding of working within a Quality Management System (QMS) framework, ensuring all design records, engineering changes, and technical documentation strictly comply with FDA Quality System Regulations.
• Actively participate in and support Design Controls activities, translating requirements into verifiable designs, completing component-level risk assessments (ISO 14971), and drafting protocols for design verification testing.
• Design and optimize complex injection-molded components, ranging from small, high-precision internal parts to large aesthetic exterior housings, utilizing a strong understanding of modern medical-grade resins to ensure biocompatibility, chemical resistance, and flame retardancy.
• Specify cosmetic requirements including production painting, texturing, and shielding coatings, ensuring compatibility with medical disinfectants and assembly environments.
• Develop robust structural assemblies consisting of stamped or fabricated metal frames integrated with mounted custom plastic covers, using GD&T to manage tolerance stack-ups and ensure seamless fit, finish, and aesthetic alignment.
• Act as the primary technical contact with tooling vendors and contract manufacturing partners.
• Drive Design for Manufacturability (DFM) feedback loops to optimize tool designs, mold flow analyses, and assembly workflows.
• Design and build custom test fixtures, write detailed verification test procedures, and execute testing scenarios to validate part and assembly performance. Troubleshoot mechanical failures or deviations during developmental and pilot production phases.
• Demonstrates a high degree of autonomy. Independently manages and owns major subsystems from initial concept through design verification testing.
• Formally mentors associate engineers. Actively conducts peer code/design reviews of CAD models and drawings to ensure GD&T principles are applied correctly.
• Routinely presents subsystem design progress and technical challenges to R&D management; translates complex mechanical concepts into clear, actionable project status updates.
• Leads technical design reviews for their assigned subsystems. Collaborates closely with Systems, Electrical, and Embedded Software engineers to align on electrical-mechanical interfaces and actuator requirements.
• Translates high-level system requirements into specific mechanical requirements. Evaluates and manages risk files (FMEA) for complete subsystems and assists in defining sub-assembly testing protocols for design verification.
• Other duties as needed or required.

QualificationsMinimum Requirements & Qualifications

• Bachelor’s degree in Mechanical Engineering; graduate degree preferred.
• 4-9+ years of relevant mechanical design experience, preferably in medical devices, lasers, or capital equipment.
• 5+ years of CAD design experience; SolidWorks preferred.
• Extensive knowledge of manufacturing technologies, including injection molding, sheet metal fabrication, and high-precision machining.
• Experience designing and assembling miniature optical components using solder, adhesives, and advanced fastening techniques for laser applications.
• Experience collaborating with clinical personnel to develop medical devices that meet ergonomic and usability requirements.
• Experience designing, assembling, and testing rapid-turn prototypes using rapid prototyping, machining, and off-the-shelf components.
• Strong understanding of GD&T principles and their application to precision mechanical designs.
• Experience using FEA simulation tools and correlating simulation results with empirical test data.
• Experience designing thermal management systems, including air- and water-cooled heat exchangers and thermoelectric coolers.
• Experience designing actuation assemblies, such as laser beam scanning systems and translation and rotation stages.
• Experience designing opto-mechanical assemblies, including strain-free optical mounting techniques using adhesives.
• Familiarity with FDA Quality System Regulations, Design Controls, IEC 60601, and/or ISO 14971 Risk Management requirements.
• Working knowledge of electronics, optics, and numerical data analysis tools such as Excel, MATLAB, or equivalent.

Preferred Qualifications

• Experience with thermal FEA tools.
• Experience with data acquisition systems such as LabVIEW.
• Experience developing laser or energy-based medical devices.