Sr. Device Engineer

Job Summary

Roles & Responsibilities

• Cook up and oversee combination product change control records.
• Launch, pass on, and seal change records for product and manufacturing process alterations.
• Launch, pass on, and seal change records for the design and development of drug device combination products, encompassing the crafting and oversight of design control documents.
• Manage the execution of changes at various manufacturing sites and closure of change records.
• Collate surveillance data into annual reports.
• Create yearly 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.

Qualifications

• 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 collaborate with team members, vendors, suppliers, and contract manufacturers to coordinate changes.

Education & Experience

• 3-5 years relevant experience in related fields.
• A Bachelor's or Master's degree in a relevant field.
• Experience with medical device development and/or pharmaceutical operations (cGMP environment) required.