Job Title: Product Development Engineer

Company Description

ASI Dental Specialties has been a leader in designing and manufacturing advanced dental equipment in Colorado since 1992 and is renowned for its innovative integrated dental delivery systems.

About Us

We are a small, agile dental equipment manufacturer dedicated to designing and producing advanced dental delivery systems. These systems serve as the central hub in dental operatories, providing seamless integration of air, water, electricity, vacuum, and controls for handpieces. 

ASI provides unique and customizable solutions for modern treatment centers. Our systems incorporate ergonomic designs and support a wide variety of preferred dental instruments, enabling seamless integration through a single foot control. ASI’s engineering advancements ensure easy upgrades and adaptabilities to new dental technologies, reflecting our commitment to excellence and innovation.

Our focus is on reliability, ergonomics, and compliance with stringent medical standards to support dental professionals in delivering exceptional patient care.

Role Description

This is a full-time, on-site role for a Product Development Engineer based in Englewood near Lone Tree, CO.

The Product Development Engineer will be responsible for conceptualizing, designing, testing, and refining/improving our integrated delivery systems and related dental instruments, components and equipment. This role includes collaborating with cross-functional teams on innovative product designs, conducting research and development (R&D), and enhancing product functionality to meet the evolving needs of the dental industry while maintaining the highest standards in quality and technology.

This position combines strong mechanical design expertise with project management skills in a small-company setting, where you'll manage projects from concept through production while ensuring full compliance with safety standards for medical electrical equipment. Ideal for a versatile engineer who thrives in a collaborative, fast-paced environment with direct impact on product outcomes.

Key Responsibilities

Lead and manage product development projects from initial concept through prototyping, testing, verification, validation, and production transfer, including timeline, resource coordination, and cross-functional communication (with manufacturing, quality, regulatory, and sales teams).

Design and develop mechanical and electromechanical components and assemblies for dental delivery systems using SolidWorks (3D CAD modeling, assemblies, detailed drawings, and tolerance analysis).

Ensure all designs comply with IEC 60601-1 and related international requirements for basic safety and essential performance of medical electrical equipment, including risk management (ISO 14971), electrical safety, mechanical hazards, and essential performance criteria.

Create and maintain design documentation, including product specifications, Bills of Materials (BOMs), engineering change orders (ECOs), and Design History Files (DHF) in alignment with quality management systems.

Perform feasibility studies, concept generation, material selection, and tolerance stack-up analysis to optimize designs for manufacturability, cost, reliability, and ergonomics.

Develop prototypes, conduct hands-on testing (including functional, reliability, and safety testing), analyze results, and iterate designs to meet performance and regulatory requirements.

Collaborate with suppliers and manufacturing teams to resolve design-for-manufacturing issues, support process validation, and implement design improvements for existing products.

Participate in risk assessments, FMEA (Failure Modes and Effects Analysis), and compliance activities to support regulatory submissions (e.g., FDA 510(k) where applicable).

Provide technical support for production troubleshooting, sustaining engineering, and continuous improvement initiatives.

Stay current with industry standards, emerging technologies in dental equipment, and best practices in medical device development.

Qualifications

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.

3–7+ years of experience in product development or design engineering, preferably in medical devices, dental equipment, or similar regulated industries.

Proficiency in SolidWorks (or comparable 3D CAD software) required, with experience in complex assemblies, sheet metal, weldments, and GD&T (Geometric Dimensioning and Tolerancing).

Working knowledge of IEC 60601-1 standards for medical electrical equipment safety and essential performance.

Experience with medical device design controls, risk management (ISO 14971), and quality systems (ISO 13485 preferred).

Strong project management skills with the ability to handle multiple priorities in a small-team environment.

Excellent problem-solving abilities, attention to detail, and hands-on prototyping/testing experience.

Effective communication skills for collaborating with internal teams and external vendors.

Preferred Skills/Experience

Background in dental or medical equipment (e.g., fluidics, pneumatics, ergonomics for operatories).

Familiarity with electromechanical systems, fluid/air delivery components, or sterilization-compatible materials.

Experience with rapid prototyping tools (3D printing, CNC), FEA (Finite Element Analysis), or simulation software.

Knowledge of FDA regulations or experience supporting regulatory submissions.

What We Offer

Opportunity to make a direct impact in a small, growing company where your ideas shape products.

Collaborative, supportive team environment.