Device Engineer Jobs in California (NOW HIRING)

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Job Description
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.
Job 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.

Knowledge & Skills

• 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.

• 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

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), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
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