Senior Engineer, Project

ICU Med Careers • Salt Lake City, UT

76d

About The Position

The Senior R&D Engineer will play a critical role in driving the design, development, and implementation of medical devices. This role involves collaborating closely with cross-functional teams—including marketing, commercial, quality, regulatory, and medical groups—to ensure that all product designs meet regulatory standards and customer expectations. As a subject matter expert (SME) in medical device development, the Senior R&D Engineer will lead key projects of significant complexity while applying sound engineering principles, experimental methods, and analytical techniques. The ideal candidate will bring extensive hands-on experience in medical device design and development, with a strong background in documentation, testing, and risk management.

Requirements

• Demonstrated experience in leading and managing cross-functional teams to achieve project objectives.
• Extensive hands-on experience developing and improving medical devices, including knowledge of FDA regulations and ISO standards.
• Strong capability in 3D modeling and design for manufacturability using SolidWorks.
• Deep understanding of medical-grade plastics, injection molding principles, and common joining methods.
• Strong ability to apply statistical methods, including Design of Experiments (DOE), to solve complex engineering problems.
• Ability to effectively communicate with technical and non-technical stakeholders across departments.
• Solid understanding of the principles underlying mechanical design.
• Understanding of basic machining operations and drafting standards.

Responsibilities

• Provide project and technical leadership for device development.
• Lead small projects with the support of an established Core Team through the medical device product life cycle of development, qualification, manufacturing, and commercial release process.
• Communicate with external partners to meet project goals.
• Manage program budget: functional expenses, capital requests, and forecasts.
• Identify resources needs, costs, program schedule, key milestones, scope, and report the progress to the established plan.
• Oversee all aspects of design control, including Requirements Management, Design Outputs, Verification & Validation (V&V), Design History File (DHF), and Risk File management.
• Plan, design, and implement new products, ensuring compliance with applicable medical device standards.
• Apply experimental, computational, and analytical methods to address technical challenges and ensure product performance.
• Create and maintain product specifications, requirements, architecture, design, and usability documents.
• Design and execute exploratory, bench, and V&V testing, developing test protocols and generating comprehensive reports.
• Partner with marketing, quality, and regulatory teams to ensure design requirements align with business objectives and regulatory compliance.
• Utilize SolidWorks to create and refine device models for various product lines, with a focus on high-volume disposable medical devices.
• Collaborate with customers and suppliers to refine designs and ensure manufacturability, with an emphasis on plastics/polymer engineering and injection molding.
• Act as a technical consultant, providing guidance on engineering best practices and mentoring junior engineers.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree