New Product Introduction Development Engineer (Medical Device)

About the role

The NPI Development Engineer plays a critical role in designing, developing, and testing innovative medical technologies that improve patient care and healthcare outcomes. This role involves conducting research, prototyping new devices, improving existing products, and ensuring compliance with regulatory standards (FDA, ISO 13485, etc.).

Responsibilities

• Design, prototype, and test innovative medical devices based on clinical needs.
• Ensure designs meet FDA, ISO 13485, and other industry standards.
• Conduct risk assessments, verification & validation (V&V), and performance testing.
• Prepare technical reports, design control documents, and support patent filings.
• Work with cross-functional teams, including clinicians, regulatory, quality, and manufacturing teams.

Requirements

• Acquired 2+ years of experience in engineering.
• Skills include knowledge in engineering principles, basic understanding of statistical analysis tools and software (such as Minitab), CAD proficiency in creating both solid models and finished drawings (SolidWorks preferred).
• A Bachelor of Science or related technical degree, or equivalent professional engineering experience.
• Must be able to successfully perform the following minimum physical, cognitive, and environmental job requirements with or without accommodation for this position.
• A team player, organized, and effective at communicating problems to all levels of the organization succinctly.

Qualifications

Acquired 2+ years of experience in engineering.

Skills include knowledge in engineering principles, basic understanding of statistical analysis tools and software (such as Minitab), CAD proficiency in creating both solid models and finished drawings (SolidWorks preferred).

A Bachelor of Science or related technical degree, or equivalent professional engineering experience.

Must be able to successfully perform the following minimum physical, cognitive, and environmental job requirements with or without accommodation for this position.

A team player, organized, and effective at communicating problems to all levels of the organization succinctly.

Skills

Knowledge in engineering principles, basic understanding of statistical analysis tools and software (such as Minitab), CAD proficiency in creating both solid models and finished drawings (SolidWorks preferred).

Benefits

Details about our benefits can be found here.

Pay

The pay range for this position in Colorado is $73,500 to $117,600.00. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

Schedule

This is an office role.

Contact

Interested candidates are encouraged to apply as soon as possible to ensure consideration.