Product Development Engineer II

Applied Medical•Rancho Santa Margarita, CA

1d•Onsite

About The Position

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. The Product Development Engineer plays a critical role in leading the design and development of medical device components, assemblies, and systems from concept through production. This role focuses on early-stage product development, including concept generation, prototyping, and iterative design refinement. The Product Development Engineer works closely with surgeons, cross-functional engineering teams, and manufacturing partners to translate clinical needs into functional, manufacturable designs. This position requires strong ownership, independent problem-solving, and the ability to contribute innovative solutions while supporting and collaborating with other engineers.

Requirements

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.

Nice To Haves

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 workstreams.

Responsibilities

Lead the design and development of medical device components, assemblies, and systems from early concept through prototyping, testing, and production readiness.
Develop high-quality CAD models, drawings, and assemblies with proper application of engineering standards, including GD&T.
Design and develop prototypes, fixtures, tools, and equipment to support product development and manufacturing processes.
Identify technical challenges, conduct root cause analysis, and develop effective, innovative design solutions.
Collaborate with cross-functional teams, including engineering, manufacturing, and quality, to ensure designs are practical and manufacturable.
Engage in iterative design processes, incorporating feedback from testing, team members, and end users.
Participate in or support interactions with clinicians to better understand user needs and translate them into design requirements.
Prepare and maintain technical documentation, including drawings, test methods, validation protocols, and reports.
Contribute to design reviews, brainstorming sessions, and continuous improvement initiatives.
Support and collaborate with other engineers by sharing knowledge and contributing to team development.