Sr Medical Device Engineer (Combination Products)

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.