Engineer, R&D

Title: Engineer, R&D

Location: Santa Clara, CA (100% Onsite)

Duration: 12Months

Pay Range: $54/hr to $59/hr (On W2)

Shift Time: 8am to 5pm

We are looking for a “Engineer, R&D“ to join one of our Fortune 500 clients.

Job Summary

As an R&D Sustaining Engineer, you will be part of the 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.

This is an onsite opportunity based in Santa Clara, CA.

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.

We are looking for the candidate who are eligible to work with any employers without sponsorship.

If you’re interested, please click “Apply” button