Sr Medical Device Engineer (Combination Products)

Sr Medical Device Engineer (Combination Products) Foster City, CA Apply Now Back to Search The Fountain Group is seeking a national staffing firm and are we are currently seeking a Sr Medical Device Engineer for a prominent client of ours. This position is located in Foster City, CA and operates on a remote (onsite as needed) . Details of the position are as follows: Job Details: • Pay: $80.00 to 100.00/HR Overview: The Device Engineering team 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 post market surveillance reports, risk management file maintenance, and general project management across the combination product portfolio. 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. Manage implementation of changes at multiple manufacturing sites and change record closures. 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 and documentation. Act as a central hub between cross-functional teams to ensure supply continuity. Required 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. Experience with Veeva Vault. 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. Ability to work with team members, vendors, suppliers, and contract manufacturers to coordinate changes. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy #LI-AB1 Apply Now Back to Search Success! Your application was successfully sent! Error Apply Now Not yet ready to apply? Join our talent community