Device Engineer - V*

Senior Technical Specialist (Device Engineering) 1 Year Contract

Foster City, CA (Onsite)
Duration: 12 Months (Contract)

Job Overview

We are seeking a Senior Technical Specialist to support drug-device combination products throughout the commercial lifecycle. This role focuses on change control management, design control documentation, and regulatory compliance within a cGMP-regulated environment.

The ideal candidate will have experience in medical devices and/or pharmaceutical operations, along with strong organizational and project coordination skills.

Key Responsibilities

• Manage and coordinate change control records for product, process, and design changes
• Initiate, route, and close change records in a regulated environment
• Support design control documentation for combination products
• Coordinate test sample builds, including procurement and logistics
• Compile and maintain post-market surveillance reports
• Generate risk management summaries and maintain risk files
• Assist with complaint investigations
• Collaborate with cross-functional teams, vendors, and contract manufacturers

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field
• 3 5 years of relevant experience in medical device, biotech, or pharmaceutical industry
• Experience working in a cGMP-regulated environment
• Strong understanding of change control processes
• Experience with design control and/or risk management
• Excellent organizational and time management skills
• Ability to manage multiple priorities and coordinate across teams

Preferred Qualifications

• Experience with drug-device combination products
• Familiarity with post-market surveillance activities
• Knowledge of EU medical device regulations
• Experience with Veeva Vault
• Exposure to ISO 13485 / risk management standards (ISO 14971)