Senior Medical Device R&D Engineer: Verification Lead

Abbott (abbottcareers2 board); Santa Clara (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Free HIP PPO medical plan next kalndar

Excellent retirement savings with high

Tuition reimbursement and FreeU

Job summary

Abbott in Santa Clara, CA is seeking a Senior Product Development Engineer to lead design verification of medical device systems. You will develop test methods, author protocols and reports, and drive engineering solutions through design changes in a fast-paced R&D environment.

This senior IC role requires hands-on product development experience, strong GD&T and SolidWorks skills, and the ability to mentor junior engineers while maintaining compliance with FDA and ISO standards.

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering.
• 5+ years of engineering experience in medical device product development or a regulated environment.
• Experience leading significant design verification and product development activities.
• Experience conducting failure investigations and applying structured root cause analysis techniques.
• Proficiency with SolidWorks and experience creating CAD models, assemblies, drawings, and product documentation.
• Working knowledge of GD&T and tolerance stack analysis.
• Strong technical writing, communication, analytical, and problem-solving skills.
• Experience defining product specifications, engineering requirements, and design inputs.
• Ability to independently lead complex technical projects while collaborating with cross-functional teams.
• Experience with catheter-based, minimally invasive, implantable, or disposable medical devices.

Responsibilities

• Lead design verification activities for medical device systems and subsystems, including development of protocols, test methods, and fixtures; test execution, statistical data analysis, and report authorship.
• Lead failure investigations, root cause analyses, and implementation of design improvements and corrective actions.
• Design mechanical components, assemblies, fixtures, prototypes, and test hardware using SolidWorks, and develop associated engineering documentation including drawings, specifications, and BOMs.
• Support product development through concept evaluation, prototyping, testing and design refinement.
• Apply engineering analysis, risk management principles, GD&T, tolerance stack-ups, and sound engineering judgment to drive technical decisions.
• Support supplier development, component qualification, manufacturing readiness, and design transfer activities.
• Communicate technical findings through reports, presentations, and design reviews, while providing technical leadership, mentorship, and guidance to junior engineers.
• Maintain compliance with Abbott procedures and documentation requirements, FDA regulations, ISO standards, and applicable quality system requirements.

Skills

Design verification

Root cause analysis

Technical communication

Project leadership

Cross-functional collaboration

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

CAD software

Job description

Abbott in Santa Clara, CA is seeking a Senior Product Development Engineer to lead design verification of medical device systems. You will develop test methods, author protocols and reports, and drive engineering solutions through design changes in a fast-paced R&D environment.

This senior IC role requires hands-on product development experience, strong GD&T and SolidWorks skills, and the ability to mentor junior engineers while maintaining compliance with FDA and ISO standards.