Product Development Engineer II

About the role

The Product Development Engineer at Applied Medical plays a critical role in 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.

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.

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.

Preferred

• 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.

Benefits

• Competitive compensation range: $75,000 - $120,000 / year (California).
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Educational reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.