Device Engineer III

Gilead Sciences•Foster City, CA

About The Position

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.

Requirements

Development and manufacturing of medical devices in accordance with ISO 13485.
Risk management in accordance with ISO 14971.
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.
5+ years of relevant experience with a BS or BA in a related field; or 3+ years of relevant experience with an MS

Nice To Haves

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.

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.