Design Engineer II

Applied Medical•Rancho Santa Margarita, CA

15h•Onsite

About The Position

The Design Engineer II contributes to Applied Medical's Technology and Development Mechanical team by designing and developing medical device components, assemblies, and fixtures that directly support the advancement of surgical technology. Working onsite at Applied Medical's global headquarters, this role operates within a cross-functional team environment to take products from concept through detailed design, documentation, and integration into the manufacturing process. The Design Engineer II applies mechanical engineering principles, Computer-Aided Design (CAD) modeling, and hands-on prototyping skills to solve complex design challenges and deliver solutions that meet rigorous quality and regulatory standards. Professionals with backgrounds in mechanical design engineering, biomedical device development, product development engineering, or manufacturing engineering will find this role a strong fit.

Requirements

Two to three years of relevant mechanical or product design engineering work experience.
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, Manufacturing Engineering, or an equivalent field.
Proficiency in CAD modeling and drafting, including experience with SolidWorks or comparable three-dimensional design software.
Working knowledge of Geometric Dimensioning and Tolerancing (GD&T) and its application in engineering drawings and design specifications.
Hands-on experience building and evaluating physical prototypes as part of an iterative product development process.
Strong technical writing skills with the ability to prepare and maintain clear, complete design documentation.
Excellent organizational and communication skills with the ability to work effectively in cross-functional team environments.
Demonstrated ability to analyze complex systems, identify root causes, and develop innovative solutions independently.

Nice To Haves

Experience in the medical device industry, with familiarity with surgical applications and clinical needs.
Understanding of manufacturing and quality standards, including Food and Drug Administration (FDA) regulations and ISO quality systems.
Exposure to Failure Mode and Effects Analysis (FMEA) and Test Method Validation processes.
Experience with product lifecycle management software, including SAP NetWeaver or equivalent Product Lifecycle Management (PLM) platforms.
Experience using Minitab or other statistical analysis software for design verification and validation activities.
Experience applying Finite Element Analysis (FEA) and hand calculations to evaluate component strength, stress, and reliability.

Responsibilities

Design and develop medical device components, assemblies, and fixtures using CAD software, including two-dimensional and three-dimensional modeling and detailed engineering drawings in SolidWorks.
Prepare and maintain comprehensive design documentation, including drawings, specifications, design reviews, and supporting technical materials that meet Applied Medical's quality and regulatory standards.
Apply Geometric Dimensioning and Tolerancing (GD&T) principles to ensure design intent is accurately communicated and manufacturable within specification.
Build and test physical prototypes hands-on to validate design concepts, evaluate performance, and identify opportunities for improvement prior to production.
Identify and resolve design issues by analyzing root causes, generating solution concepts, and implementing changes in a structured and documented manner.
Collaborate with cross-functional teams, including engineers, product managers, and manufacturing teams, to ensure seamless integration of designs into the broader product development process.
Contribute to design reviews, risk analyses, and validation activities in support of regulatory compliance and product quality objectives.
Stay current on engineering principles, materials, manufacturing processes, and emerging design technologies relevant to medical device development.