KH
Sr. Device Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Senior
4 months ago
- Risk Management
- Veeva Vault
4 months ago
Not enough detail in this posting to match
- 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.
- 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.
- 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.
- 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.
Sr. Device Engineer · Katalyst Healthcares & Life Sciences