Senior Device Engineer - Change Control & Lifecycle Lead

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

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.