Job Details

Job title: Device Engineer - V

Location: Foster City CA

Duration: 12+ Months

Pay rate:$80 - $100/hr.

Overview

The Device Engineering team is seeking a highly organized and detail-oriented Senior Technical Specialist to support drug-device combination products throughout their commercial lifecycle. This role is critical in ensuring compliant change management, effective cross-functional coordination, and ongoing product quality within a regulated environment.

Key Responsibilities

Change Control Management

• Initiate, coordinate, and close change control records for product and manufacturing process updates
• Manage change records related to design and development activities for combination products
• Support the creation and maintenance of design control documentation

Test Sample Coordination

• Manage test sample requests, procurement, and tracking
• Coordinate logistics for timely delivery of test samples across teams and external partners

Post-Market Surveillance & Risk Management

• Compile and analyze post-market surveillance data for annual reporting
• Generate risk summaries and maintain risk management files
• Support complaint investigations and ensure proper documentation

Cross-Functional Collaboration

• Work closely with internal teams, vendors, suppliers, and contract manufacturers to coordinate changes and ensure compliance
• Support quality and regulatory activities aligned with global standards

Required Qualifications

• Bachelor's degree (BS/BA) in Engineering, Life Sciences, or a related field
• 3–5 years of experience in medical devices, pharmaceuticals, or combination products
• Experience working in a regulated environment (cGMP/GMP)

Preferred Qualifications

• Experience with drug-device combination products
• Working knowledge of global regulations (US, EU, international)
• Familiarity with Veeva Vault or similar quality management systems
• Experience with risk management tools (e.g., FMEA, ISO 14971)
• Exposure to design controls and product development processes

Key Skills

• Strong organizational and time management abilities
• Excellent project coordination skills
• Attention to detail and documentation accuracy
• Ability to manage multiple priorities in a fast-paced environment
• Effective communication and collaboration skills

Nice to Have

• Device development experience (for candidates aligning with Sr Device Engineer level)