Device Engineer III

About the role

We are seeking a highly motivated, detail-oriented Device Engineer III to support drug-device combination products across the commercial lifecycle. The successful candidate will support commercialization and sustaining engineering activities for combination drug/medical devices, from design transfer through ongoing commercial support. This role requires expertise in design controls, risk management, change management, and complaint management.

Responsibilities

• Represent Device Development on commercial CMC and business continuity teams, and communicate technical findings and project updates clearly to project teams and stakeholders.
• Implement post-launch changes, support complaint handling and investigations, and investigate and close out deviations.
• Perform risk management reviews and updates in accordance with ISO 14971.
• Maintain the Design History File (DHF) throughout the commercial lifecycle.
• Support business continuity activities, including second sourcing.
• Support manufacturing site selection and other late-stage development activities.
• Execute design transfer activities to internal and external manufacturing sites.
• Author, review, and approve technical documentation, including design control records, test methods, protocols, reports, and risk management documentation.

Requirements

Candidates must have experience and knowledge in all of the following areas:

• Development and manufacturing of medical devices in accordance with ISO 13485.
• Risk management in accordance with ISO 14971.

The candidate must have experience and knowledge in one or more of the following areas:

• Root cause analysis, deviation management, and investigations.
• Lifecycle change control management for combination products.
• Management of combination product-related complaints.
• Experience working with vendors, suppliers, and contract manufacturers to implement changes or investigate product and process performance issues.
• Design, execution, and statistical analysis of process characterization studies.

Qualifications

Candidates with experience and knowledge in the following areas will be considered especially well qualified:

• Design transfer to internal and external manufacturing sites and partners.
• Familiarity with common mechanical assembly processes used in drug injection and delivery systems.
• Experience with Solidworks, Onshape, or Fusion 360.
• Familiarity with the requirements of ICH Q7, Q8, Q9, and Q10.
• Experience with project management methods and tools.
• Experience with basic statistical methods, including design of experiments, components of variance analysis, and statistical tolerancing.

Education & Experience

5+ years of relevant experience with a BS or BA in a related field; or 3+ years of relevant experience with an MS.

Pay

The salary range for this position is $117,895.00 - $152,570.00. 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).

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Paid time off.

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For additional benefits information, visit Gilead Benefits.