Sr Device Engineer I

Job Description

The Device Engineering team at Gilead is seeking a qualified Senior Device Engineer to drive commercial readiness and life cycle management of drug-device combination products.

This individual will be responsible for supporting manufacturability assessments, design verification builds, clinical builds, design transfer, commercialization activities, and commercial sustaining support. This role requires expertise in design controls, process development, product/technology transfer, and process validation.

Job Responsibilities

• Manage technical issues with legacy device components of combination products to ensure supply chain continuity.
• Lead device process engineering efforts on late-stage device project teams and Commercial CMC teams.
• Manage manufacturability assessments on the product during early design and development.
• Manage design verification and clinical product manufacturing builds.
• Support manufacturing site selection activities.
• Perform risk management per ISO 14971.
• Lead design transfer to internal and external manufacturing sites, executing process characterization studies, selecting and specifying manufacturing equipment, and authoring/reviewing design control documents.
• Manage commercial change controls and support complaints handling/investigations and deviations.

Knowledge & Skills

• Deep experience running multifunctional teams to manage technical issues at contract manufacturing organizations.
• Deep experience and knowledge in medical device development and commercialization, process validation, and related global regulatory requirements.
• Experience with design, execution, and statistical analysis of process characterization studies.
• Execution of root cause analysis, deviation management, and investigation.
• Experience working with equipment vendors and manufacturers including creating RFPs, developing user requirements, and qualifying equipment.
• Strong verbal, written, and interpersonal communication skills are required.
• Must be able to write clear, concise, and error-free documents.

Basic Qualifications:

• Doctorate OR
• A Bachelor’s Degree in mechanical engineering, chemical engineering, biomedical engineering, material science, or a related scientific field and a minimum of six (6) years of relevant industry experience, OR
• Master’s Degree in mechanical engineering, chemical engineering, biomedical engineering, material science, or a related scientific field and a minimum of four (4) years of relevant industry experience

Preferred Qualifications:

• Deep experience running multifunctional teams to manage technical issues at contract manufacturing organizations.
• Deep experience and knowledge in medical device development and commercialization, process validation, and related global regulatory requirements.
• Experience with design, execution, and statistical analysis of process characterization studies.
• Execution of root cause analysis, deviation management, and investigation.