Contract Mechanical Engineer

Contract Mechanical Engineer – Medical Device Development

Contract | On-Site in Morrisville, NC

Important: This position requires full-time, on-site work in Morrisville, North Carolina. Remote work is not available.

We are not accepting submissions from third-party staffing vendors and cannot consider C2C arrangements.

Company Overview

Our client is an innovative medical technology company developing advanced, non-invasive monitoring systems. Its technologies provide deeper insight into physiological changes and capture signals associated with muscle and brain activity. The company is also advancing novel sensing solutions designed to perform reliably in demanding real-world environments.

This is an opportunity to join a growing, multidisciplinary team working to improve how health data is measured, understood, and used.

Position Overview

We are seeking an experienced Mechanical Engineer to support the development of wearable and medical monitoring technologies. Working closely with mechanical, electrical, biomedical, and scientific team members, this individual will help translate technical and customer requirements into practical, manufacturable hardware solutions.

The engineer will contribute across the product development lifecycle—from early prototypes and mechanical architecture through design refinement, testing, issue resolution, and preparation for production. The successful candidate will be comfortable balancing multiple development priorities in a fast-moving, collaborative environment.

Key Responsibilities

• Develop mechanical components and assemblies for wearable monitoring and medical device systems.
• Translate product, customer, and system requirements into detailed mechanical designs.
• Design rigid and flexible enclosures, molds, fixtures, prototype assemblies, and optical interfaces using SolidWorks.
• Collaborate with cross-functional engineering and scientific teams to integrate mechanical designs with electronic, optical, and software-based systems.
• Identify, document, prioritize, and help resolve open hardware design issues.
• Build and evaluate prototypes to confirm fit, function, durability, usability, and performance.
• Support the transition of prototype designs into repeatable, scalable production processes.
• Incorporate design-for-manufacturing, assembly, and testing principles throughout development.
• Develop fixtures, molds, and other tools needed for prototyping, verification, and production readiness.
• Ensure designs consider applicable medical device safety, usability, quality, and regulatory requirements.
• Maintain clear design documentation and communicate project status, risks, and recommended solutions to stakeholders.

Required Qualifications

• Bachelor’s or master’s degree in Mechanical Engineering, Biomedical Engineering, or a closely related discipline.
• At least eight years of relevant industry experience, including work with wearable monitoring systems, medical devices, or similarly regulated products.
• Advanced SolidWorks proficiency, including experience designing enclosures, molds, fixtures, and mechanical or optical interfaces.
• Demonstrated success advancing early-stage prototypes toward production.
• Hands-on experience with rapid prototyping techniques and prototype subassembly development.
• Working knowledge of Design for Manufacturing (DFM), Design for Assembly (DFA), and Design for Test (DFT).
• Familiarity with medical device standards and regulatory expectations, including IEC 60601, ISO 10993, ISO 13485, ISO 14971, IEC 62366, and applicable FDA guidance.
• Strong problem-solving, organizational, and cross-functional communication skills.
• Ability to perform effectively in a fast-paced product development environment.

Preferred Qualifications

• Experience developing waterproof, moisture-resistant, or corrosion-resistant products.
• Experience designing devices or components that directly interface with the human body.
• Background in wearable sensors, physiological monitoring, optical systems, or ruggedized medical technology.

Contract Details

• Location: Morrisville, NC—on-site
• Schedule: Approximately 35–40 hours per week
• Duration: Initial contract of at least three months
• Compensation: Hourly or engagement rate will be based on the selected candidate’s qualifications and experience
• Engagement type: Direct applicants only; no third-party vendors or C2C arrangements