Device Engineer & Change Control Lead

ACL Digital; San Mateo (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

ACL Digital is looking for a Device Engineer/Project Coordinator II located in Foster City, CA. This role involves supporting drug device combination products throughout their lifecycle by managing change control records, post-market surveillance, and project management efforts.

The ideal candidate will have 3-5 years of relevant experience in medical device or pharmaceutical operations, strong organizational skills, and familiarity with regulations. The position is onsite, five days a week.

Qualifications

• 3 – 5 years relevant experience in related field required.
• Experience with medical device development and/or pharmaceutical operations in a cGMP environment.

Responsibilities

• Coordinate and manage combination product change control records.
• Coordinate post-market surveillance reports and risk management file updates.
• Support complaint investigations and documentation.
• Act as a central hub between cross-functional teams.

Skills

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 regulations

Experience with Veeva Vault

Ability to work with team members and vendors

Education

BS or BA in a related field

Job description

ACL Digital is looking for a Device Engineer/Project Coordinator II located in Foster City, CA. This role involves supporting drug device combination products throughout their lifecycle by managing change control records, post-market surveillance, and project management efforts.

The ideal candidate will have 3-5 years of relevant experience in medical device or pharmaceutical operations, strong organizational skills, and familiarity with regulations. The position is onsite, five days a week.