Device Engineer III
Listed on 2026-07-04
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Regulatory Compliance Specialist, Biomedical Engineer
Job Description
We are seeking a highly skilled and proactive Device Engineer III to support testing, method development, design verification and method transfer activities for medical devices and parenteral combination products, including autoinjectors, prefilled syringes, and needle‑safety systems. This individual contributor role is ideal for an engineer with strong technical fundamentals, hands‑on testing experience, and the ability to collaborate effectively across development, quality, and manufacturing teams.
The position will be part of the Device Engineering group and sits within the Verification and Testing team supporting internal lab operations, design verification, external testing activities, and method transfer to manufacturing sites.
Support design control activities, including design verification, design transfer and risk‑management deliverables.
Develop, optimize, and validate test methods for device and combination‑product components.
Execute design verification (DV) testing and prepare protocols, data summaries, and technical reports.
Assist with method transfers between internal labs, external DV labs, and manufacturing sites.
Coordinate and monitor external testing
, ensuring methods, protocols, and data meet quality and compliance standards.Contribute to lab operations
, including equipment readiness, sample coordination, and maintaining 5S/Kaizen practices.Support quality investigations (e.g., deviations, CAPAs, change controls) related to testing activities.
Represent the Device Engineering function in internal meetings, supplier interactions, and project team forums.
Communicate technical findings clearly with cross‑functional partners.
Doctorate OR Master’s and 3+ years of relevant experience OR Bachelor’s and 5+ years of relevant experience
Preferred QualificationsBachelor’s or Master’s degree in Mechanical Engineering
, Biomedical Engineering
, Chemical Engineering
, or related field.Experience in combination product development
, medical device testing, or pharmaceutical/biotech environments.Hands‑on experience with:
Understanding of design control
, risk management
, and regulatory standards (FDA, ISO 13485, ISO 14971, cGMP).Familiarity with relevant ISO standards (e.g.,
ISO 11040
, ISO 11608
, ISO 80369
).Experience with statistical techniques (e.g., ANOVA, Gauge R&R, sample size calculations) and statistical software (JMP, Minitab).
Strong communication skills, with the ability to write clear and concise technical documents.
Demonstrated ability to troubleshoot, conduct root‑cause investigations, and drive continuous improvement.
The salary range for this position is: $ - $. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits include company‑sponsored medical, dental, vision, and life insurance plans.*
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process…
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