Device Engineer - V

Job 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.

Additional Notes:

• This could also be a Sr Device Engineer who would have the addition of device development experience.