Engineer, R&D

Title: Engineer, R&D

Location: Santa Clara, CA

Duration: 12 Months

100% Onsite

Job Summary:

As an R&D Sustaining Engineer, you will be part of the Abbott R&D team supporting the on-going testing and sustainment of medical device systems. This role involves a broad range of responsibilities including packaging support, verification and validation testing, test method execution, component qualification, documentation updates, external test laboratory coordination, and manufacturing support.

This position is an individual contributor role requiring the ability to work with limited supervision while managing technical deliverables, collaborating cross‑functionally, and supporting regulatory and quality activities within a regulated environment.

Job Responsibilities:

• Sustain and support medical device systems, including packaging for sterile and non‑sterile products.
• Support verification and validation activities, including test execution, data collection and analysis, dry runs, and feasibility studies.
• Support root cause investigations and failure analysis for test failures and nonconformances.
• Coordinate external test laboratories, including scheduling, execution oversight, and report review.
• Author, review, and execute test protocols, test methods, and test reports.
• Update and maintain engineering drawings, material specifications, and bills of materials (BOMs) using document control and change management processes to support component qualification, manufacturing support, and sustaining changes.
• Communicate effectively through written documentation, verbal discussions, and technical presentations.
• Maintain compliance with Abbott procedures and documentation requirements, FDA regulations, ISO standards, and other regulatory requirements.

Education:

• Minimum of a 2-year technical certification or Associate’s degree in Mechanical Engineering Technology, Manufacturing Technology, or a related technical discipline.
• Bachelor's Degree of Science with 2–5 years of engineering experience in the medical device, biotech, or regulated hardware industry.
• Experience authoring test protocols, test methods, and test reports.
• Strong written and verbal communication skills.
• Ability to work independently and as part of a collaborative, cross‑functional team in a fast‑paced environment.

Preferred Qualifications:

• Experience with catheter‑based devices.
• Experience supporting manufacturing and design transfer activities.
• Experience with document control, change management, and BOM maintenance.
• Proficiency with SolidWorks for CAD model modifications and engineering drawing updates.
• Familiarity with ISO 13485, FDA QSR, or similar quality system regulations.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.