Design Engineer

Position Description

The Design Engineer creates new medical devices and the fixtures, equipment, and tools Applied Medical uses to manufacture them at scale. Working across every phase of development, the Design Engineer studies surgical procedures, builds and tests prototypes, and delivers production-ready designs backed by complete technical documentation. This role fits an experienced design engineer with strong computer-aided design (CAD), prototyping, and design for manufacturing (DFM) skills who wants to see original designs move from concept into surgeons’ hands. This position requires travel for regular surgeon visits and occasional hospital visits. The Design Engineer observes live surgical procedures and completes hospital vendor credentialing when required.

Key Responsibilities

• Design new products, fixtures, equipment, and tools to support medical device development and manufacturing scale-up.
• Build and test prototypes through iterative development cycles, refining designs based on surgeon feedback and test results.
• Create detailed 3D models and engineering drawings in CAD software such as Creo or SolidWorks, applying geometric dimensioning and tolerancing (GD&T) and tolerance stack-up analysis.
• Develop documentation packages, including drawings, test methods, engineering specifications, and qualification protocols.
• Execute installation qualification (IQ) protocols and participate in design verification and validation testing.
• Observe surgical procedures, document clinical challenges, and translate surgeon input into user needs.
• Refine product designs for manufacturability in partnership with research and development (R&D) and manufacturing teams.
• Collaborate with cross-functional engineering teams in brainstorming sessions and design reviews.

Success in This Role Looks Like

• Delivering original product and fixture designs ready for manufacturing with minimal rework.
• Producing clear, accurate technical documentation ready for design reviews and regulatory audits.
• Shortening development cycles through hands-on prototyping and rapid iteration.
• Translating surgeon feedback into design changes with measurable usability improvements.
• Strengthening collaboration with R&D, manufacturing, and cross-functional partners through clear communication.

Position Requirements

• Bring five or more years of hands-on engineering experience in medical device product development, or eight or more years in another highly regulated industry such as aerospace, automotive safety systems, defense, pharmaceuticals, or biotechnology.
• Hold a Bachelor of Science (BS) in mechanical engineering or biomedical engineering, or a science, technology, engineering, and mathematics (STEM) degree from an ABET-accredited program.
• Demonstrate direct experience in new product design and fixture design, including original designs and hands-on prototyping.
• Apply advanced CAD techniques, including surfacing and finite element analysis (FEA), in Creo, SolidWorks, or comparable software.
• Apply GD&T, tolerance stack-up analysis, and DFM principles to precision machined parts.
• Generate and review technical documentation, including engineering specifications, drawings, test method validation, and process characterization.
• Work comfortably in highly regulated environments.
• Solve complex engineering problems through strong analytical, organizational, and critical thinking skills.

Preferred

• Apply working knowledge of materials and material properties, pneumatics, and electromechanical design.
• Qualify new materials, manufacturing processes, fixtures, and equipment.