Job Description
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)