Sr. Device Engineer

Katalyst CRO; Foster City (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

Katalyst CRO, located in Foster City, California, seeks a qualified individual for their Device Engineering team to support drug device combination products throughout the commercial lifecycle. You will manage change control records, coordinate post-market surveillance, and ensure regulatory compliance while demonstrating exceptional organizational skills.

The ideal candidate has 3-5 years of relevant experience and a Bachelor's degree, with a background in medical device development or pharmaceutical operations in a cGMP environment.

Qualifications

• 3-5 years of relevant experience in a related field.
• Experience in medical device development or pharmaceutical operations in a cGMP environment.

Responsibilities

• Manage combination product change control records.
• Coordinate post-market surveillance reports and risk management file updates.
• Act as a hub between cross-functional teams to ensure supply continuity.

Skills

Organizational skills

Time management

Project management

Knowledge of change controls

Experience with Veeva Vault

Education

Bachelor's degree in a related field

Job description

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.

Roles & 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.
• Demonstrate exceptional organizational and time management skills.
• Demonstrate understanding of change controls in a regulated industry.
• Demonstrate experience with project management.
• Show working knowledge of relevant US, EU, and international medical device and pharmaceutical regulations.
• Demonstrate experience with Veeva Vault.
• Ability to work with team members, vendors, suppliers, and contract manufacturers to coordinate changes.

Education & Experience

• 3-5 years of relevant experience in related field and a BS or BA.
• Experience with medical device development and/or pharmaceutical operations (cGMP environment) required.