Product Development Engineer II

Applied Medical is a new-generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than is possible in typical positions.

Are you an experienced Product Development Engineer ready to drive innovation in medical device design? Join Applied Medical, where for over 35 years we have been developing and manufacturing advanced surgical technologies that transform patient care. In this role, you will lead the design and development of medical device components, assemblies, and fixtures, working onsite at our global headquarters in Rancho Santa Margarita, CA.

You’ll collaborate directly with surgeons, cross‑functional engineers, and manufacturing teams to translate clinical needs into life‑changing devices. This is a unique opportunity to take ownership of critical projects from concept through completion and directly impact the future of healthcare.

• End-to-End Product Development: Lead projects through all stages of the design cycle—from early concepting and surgeon input, to prototyping, testing, and final manufacturable designs.

• CAD Design and Modeling: Develop high‑quality CAD models, drawings, and assemblies with precise application of Geometric Dimensioning and Tolerancing (GD&T).

• Prototype and Fixture Design: Create prototypes and design fixtures, equipment, and tools that support manufacturing scale‑up and process qualification.

• Problem Solving and Innovation: Identify technical challenges, generate inventive solutions, and refine designs based on iterative testing and surgeon feedback.

• Clinical
  
  Collaboration:
  
  Observe surgical procedures, translate user needs into design requirements, and present prototypes for evaluation and feedback.

• Regulatory and Documentation Support: Prepare design documentation packages, including drawings, qualification protocols, and test methods. Participate in validation activities to ensure designs and processes meet required standards.

• Cross-Functional Leadership: Partner with R&D, Manufacturing, and Quality teams to ensure successful product transfer to production. Contribute actively to design reviews and brainstorming sessions.

• Bachelor’s degree in Mechanical or Biomedical Engineering.
• Minimum of five years of engineering experience in medical devices or another highly regulated industry.
• Demonstrated ownership of past product development projects, not just support roles.
• Strong background in Design for Manufacturing (DFM) with proven success transitioning designs into production.
• Hands‑on experience in CAD modeling and drafting, GD&T, and prototype development.
• Strong organizational, communication, and technical writing skills.
• Proven ability to analyze, troubleshoot, and design solutions for complex systems.
• Comfort working in surgical environments, including observing live procedures, when needed.

• Direct experience in the medical device industry.
• Knowledge of surgical procedures and clinical needs.
• Familiarity with FDA regulations, International Organization for Standardization (ISO) quality systems, and validation methods, including Failure Mode and Effects Analysis (FMEA) and Test Method Validation (TMV).
• Proficiency with software such as Product Lifecycle Management (PLM) tools, Minitab, or statistical analysis programs.
• Ability to meet all hospital credentialing requirements, which may include background check, drug screen and vaccinations.
• Prior experience leading project teams or work streams.

If you are passionate about developing products that directly impact patient outcomes, thrive in collaborative environments, and are excited by the opportunity to work hands‑on in a highly regulated industry, we encourage you to apply.

• Competitive compensation range: $75,000 - $120,000 / year…