Design Engineer II

Applied Medical • Rancho Santa Margarita, CA

9d • 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 support the advancement of surgical technology. The role is performed onsite at Applied Medical's global headquarters in a cross-functional team environment, taking products from concept through detailed design, documentation, and integration into manufacturing. The engineer applies mechanical engineering principles, CAD modeling, and hands-on prototyping to solve design challenges and deliver solutions that meet quality and regulatory standards.

The role is suited to professionals with backgrounds in mechanical design engineering, biomedical device development, product development engineering, or manufacturing engineering. Success involves producing accurate, manufacturable design documentation; advancing design validation through prototype iterations; identifying and resolving design problems; coordinating effectively across engineering, manufacturing, and product management; and growing technical depth and design ownership while upholding quality, documentation, and regulatory requirements.

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 SolidWorks or comparable 3D design software.
• Working knowledge of GD&T and its application in engineering drawings and design specifications.
• Hands-on experience building and evaluating physical prototypes as part of iterative product development.
• Strong technical writing skills and ability to prepare and maintain clear, complete design documentation.
• Excellent organizational and communication skills and ability to work effectively in cross-functional teams.
• Ability to analyze complex systems, identify root causes, and independently develop innovative solutions.

Nice To Haves

• Experience in the medical device industry, with familiarity with surgical applications and clinical needs.
• Understanding of manufacturing and quality standards, including FDA regulations and ISO quality systems.
• Exposure to FMEA and Test Method Validation processes.
• Experience with product lifecycle management software, including SAP NetWeaver or equivalent PLM platforms.
• Experience using Minitab or other statistical analysis software for design verification and validation activities.
• Experience applying 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 2D and 3D modeling and detailed engineering drawings in SolidWorks.
• Prepare and maintain design documentation, including drawings, specifications, design reviews, and supporting technical materials that meet quality and regulatory standards.
• Apply GD&T principles so design intent is communicated accurately and designs are manufacturable within specification.
• Build and test physical prototypes to validate design concepts, evaluate performance, and identify improvements before production.
• Analyze root causes of design issues, generate solution concepts, and implement changes in a structured and documented manner.
• Collaborate with engineers, product managers, and manufacturing teams to integrate designs into the 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.

Benefits

• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.
• Competitive compensation range of $75,000–$95,000 per year in California; compensation may depend on education, qualifications, and experience and may be adjusted. Special discretionary bonus or incentive compensation plans may apply.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level