Device Engineer - V*

333 Lakeside Drive, CA, US • Posted 2 hours ago • Updated 32 minutes ago

Contract W2

On-site

$95/hr

Fitment

Dice Job Match Score™

🎯 Assessing qualifications...

Job Details

Skills

Regulatory Compliance
Pharmaceutics
Project Coordination
Documentation
Procurement
Logistics
Collaboration
Life Sciences
Pharmaceutical Industry
Good Manufacturing Practice
Change Control
Design Controls
Management
Surveillance
Medical Devices
Veeva
ISO 13485
Risk Management
ISO 9000

Summary

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)

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91082005
Position Id: 2026-25640
Posted 2 hours ago

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