Mechanical Engineer

XCIX Design, LLC

Location: Richmond, Utah

Job Type: Full-Time

Salary: $65,000–$105,000 annually, depending on experience

About XCIX Design

XCIX Design is a small engineering and manufacturing company specializing in the development of orthopedic medical devices, particularly spinal implants and surgical instruments.

We work with medical device companies throughout the product development process, from initial concepts and prototyping through design verification, manufacturing, regulatory submission, and ongoing quality support.

As a small company, our engineers have the opportunity to work on a wide variety of projects and take ownership of their work. We are looking for someone who enjoys solving challenging engineering problems, working independently, and seeing their designs become real products.

Position Overview

We are looking for a Mechanical Design Engineer with engineering experience to join our team.

The ideal candidate will have experience developing mechanical products, preferably within the medical device industry, and be comfortable taking projects from initial concepts through detailed design and testing.

This position involves a combination of mechanical design, product development, testing, and quality and regulatory engineering activities.

Responsibilities

* Design and develop orthopedic implants, surgical instruments, and related medical devices.

* Create and maintain 3D CAD models, engineering drawings, and product specifications.

* Develop prototypes and evaluate designs through testing and analysis.

* Plan, coordinate, and execute design verification and validation activities.

* Prepare engineering documentation, including design inputs, risk analyses, test protocols, and reports.

* Support manufacturing activities, including design for manufacturability and resolving production issues.

* Assist with quality and regulatory activities, including design controls, process validations, and technical documentation.

* Work independently on multiple projects while collaborating with other engineers, manufacturers, and customers.

Qualifications

Required:

* Bachelor’s degree in Mechanical Engineering.

* Engineering experience in mechanical design or product development.

* Proficiency with 3D CAD software, preferably SolidWorks.

* Ability to create and interpret detailed engineering drawings, including GD&T.

* Strong mechanical aptitude and understanding of materials, manufacturing processes, and mechanical design principles.

* Strong problem-solving skills, attention to detail, and ability to work independently.

* Good technical writing and communication skills.

Preferred:

* Experience in medical device development, particularly orthopedic implants or surgical instruments.

* Familiarity with FDA design controls and ISO 13485.

* Experience with design verification, mechanical testing, and validation.

* Experience with machining, additive manufacturing, or other manufacturing processes.

* Familiarity with risk management and ISO 14971.

* Experience preparing engineering documentation for regulatory submissions.

Who We’re Looking For

We’re looking for someone who is naturally curious, detail-oriented, and enjoys figuring out how things work.

The right candidate is comfortable tackling unfamiliar problems, learning new skills, and taking responsibility for completing projects.

We value practical engineering ability, initiative, and a strong work ethic. Experience working on personal engineering projects, machining, fabrication, or other hands-on technical activities is a plus.