Medical Device Engineer

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

Job Title: Device Engineer/Project Coordinator II

Location: Foster City, CA

Duration: 12 Months

Description

Onsite Position: Foster City - 5 days/week - Local Candidates

The Device Engineering team at client 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.

Job 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.

Knowledge & 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 and pharmaceutical regulations.
• Experience with Veeva Vault.
• Ability to work with team members, vendors, suppliers, and contract manufacturers to coordinate changes.

Education & Experience

• 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.