Job Details

Job Title: Senior Technical Specialist/Sr. Device Engineering - V

Location: Foster City, CA

Duration: 12 months (possible extension)

Summary:

The Device Engineering team at Client is seeking a qualified individual to support drug device combination products throughout the commercial lifecycle. This individual will be responsible for the management of combination product change records. Additional responsibilities include test sample management, post market surveillance reports, and risk management file maintenance

Job Responsibilities

• Coordinate and manage combination product change control records –
• Initiate, route, and close change records for product and manufacturing process changes.
• Initiate, route, and close change records for the design and development of drug device combination products, including the creation and management of design control documentation.
• Coordinate and manage test sample builds –
• Manage sample requests and procurement.
• Coordinate test sample delivery logistics.
• Coordinate post-market surveillance reports and risk management file updates –
• Collate surveillance information into yearly reports.
• Generate annual risk summaries and update risk management files.
• Support complaint investigations.

Knowledge & Skills

• Exceptional organizational and time management skills.
• Understanding of change controls in a regulated industry.
• Experience with project management.
• Working knowledge of relevant US, EU, and international medical device and pharmaceutical regulations.
• Experience with Veeva Vault.
• Ability to work with team members, vendors, suppliers, and contract manufacturers to coordinate changes.

Education & Experience

• 3 – 5 years relevant experience in related field and a BS or BA.
• Experience with medical device development and / or pharmaceutical operations (cGMP environment) required.
• This could also be a Sr Device Engineer would have the addition of device development experience.