Device Engineer - V

Job Description

Job Title:

Senior Technical Specialist

Location:

Foster City, CA

Duration:

12 months Description 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. Applicant Notices & Disclaimers For information on benefits, equal opportunity employment, and location-specific applicant notices, click here At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $102.67/daily.