Senior Staff Mechanical Engineer

Senior Staff Mechanical Engineer

RALEIGH - RALEIGH, NC 27615

Overview

Position Type Full Time

Description

Position Summary: We are seeking an exceptional Senior 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:

• Owns the overall mechanical Design Verification and Validation strategy. Leads system-level risk management files (ISO 14971) and ensures mechanical architectures comply with global standards like IEC 60601.
• Establish the technology roadmap for plastics and cosmetic finishing across platform projects. Direct the selection of advanced engineering resins for medical and consumer electronic applications to achieve optimal weight, cost, and reliability targets.
• Review and approve tooling architecture, mold-flow analyses, and production painting processes for critical components, ensuring high-yield, high-cosmetic-quality outcomes.
• Architect major structural platforms that integrate high-precision stamped or fabricated metal chassis with structural plastic enclosures. Define the master tolerance strategy and structural layout to survive global drop, thermal, and transit standards.
• Lead technical vendor selection and establish engineering standards for contract manufacturing (CM) partners. Coordinate closely with CMs to resolve complex tool transfers, production scaling bottlenecks, and structural yield challenges.
• Define the overall mechanical testing and validation framework for entire platforms, outlining the design of complex test fixtures, qualification procedures, and regression testing scenarios. Lead cross-functional root-cause investigations for highly complex, systemic field or production mechanical failures.
• Utilize extensive CAD design expertise in SolidWorks to architect complex, multi-subsystem mechanical layouts and define the top-down assembly structure for entire product platforms.
• Enforce SolidWorks design best practices, master modeling/skeleton techniques, and advanced GD&T application standards across the R&D engineering team.
• Lead the mechanical engineering compliance strategy within the Quality Management System (QMS) framework, defining policies that ensure all structural and opto-mechanical designs meet FDA Quality System Regulations and global medical safety standards (including IEC 60601).
• Own the system-level Risk Management strategy (ISO 14971) and govern the Design Verification and Validation (V&V) architecture for new product lines, guiding cross-functional teams to ensure robust documentation from concept through successful product launch.
• Highly self-directed. Operates as the technical lead for entire platforms. Handles ambiguous, high-risk technical problems with no pre-existing template or roadmap.
• Actively develops the engineering team's technical capabilities, identifies skill gaps, and implements training. Influences the department's engineering culture and standard design practices.
• Expected to have strong communication skills and the ability to articulate highly complex technical architectures, development timelines, and project risks directly to executive leadership.
• Initiates and chairs major cross-functional design reviews. Coordinates with Systems, Mechanical, and Embedded Software engineers to resolve multi-disciplinary integration issues.
• Other duties as needed or required.

Qualifications

Minimum Requirements & Qualifications:

• Bachelor's degree in Mechanical Engineering; graduate degree preferred.
• 10+ years of relevant mechanical design experience, preferably in medical devices, lasers, or capital equipment.
• Extensive 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.
• Strong communication and collaboration skills, with the ability to make sound design recommendations based on cross-functional input.

Preferred Qualifications:

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