Senior Medical Device Design and Verification Engineer

Abbott; Santa Clara (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Free medical coverage (HIP PPO)

Excellent retirement savings plan with

Tuition reimbursement and FreeU教育 혜택

Job summary

Abbott in Santa Clara, CA is seeking a Senior Product Development Engineer to lead design verification and develop robust medical device test methods. You will own protocols, test fixtures, and root-cause analyses while driving design changes and corrective actions.

The role demands hands-on product development, subsystem ownership, and collaboration with cross-functional teams in a fast-paced R&D environment. This onsite position requires five days per week in Santa Clara.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field.
• 5+ years in medical device product development or regulated environments.
• Experience leading significant design verification and product development activities.
• Experience with failure investigations and root cause analysis.
• Proficiency with SolidWorks; ability to create CAD models, drawings, and documentation.
• Working knowledge of GD&T and tolerance stack analysis.
• Strong technical writing and cross-functional collaboration.
• Experience defining specifications and design inputs.
• Ability to lead complex technical projects independently.
• Experience with catheter-based or implantable medical devices (preferred).

Responsibilities

• Lead design verification activities for medical device systems, including protocols, tests, and fixtures.
• Lead failure investigations and implement design improvements and corrective actions.
• Design mechanical components and test hardware using SolidWorks; create drawings and BOMs.
• Support product development through prototyping, testing, and refinement.
• Apply GD&T, tolerance analysis, and engineering judgment to drive decisions.
• Support manufacturing readiness, supplier development, and design transfer.
• Communicate findings via reports, reviews, and presentations; mentor junior engineers.
• Maintain compliance with Abbott procedures, FDA regulations, ISO standards, and QSR.

Skills

Mechanical Engineering

Medical device development

Design verification

Root cause analysis

Technical communication

Cross-functional collaboration

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Job description

Abbott in Santa Clara, CA is seeking a Senior Product Development Engineer to lead design verification and develop robust medical device test methods. You will own protocols, test fixtures, and root-cause analyses while driving design changes and corrective actions.

The role demands hands-on product development, subsystem ownership, and collaboration with cross-functional teams in a fast-paced R&D environment. This onsite position requires five days per week in Santa Clara.