Device Engineer - V

Overview

We are seeking a qualified individual to support drug-device combination products throughout the commercial lifecycle. This role is responsible for managing combination product change records, supporting test sample coordination, post-market surveillance activities, and maintaining risk management files.

Key Responsibilities

• Coordinate and manage combination product change control records
  
  • Initiate, route, and close change records for product and manufacturing process updates
  • Support change activities related to design and development, including creation and maintenance of design control documentation
• Coordinate and manage test sample builds
  
  • Oversee sample requests and procurement
  • Coordinate logistics for test sample delivery
• Support post-market surveillance and risk management activities
  
  • Compile surveillance data into annual reports
  • Generate risk summaries and maintain risk management files
  • Assist with complaint investigations

Qualifications & Skills

• Strong organizational and time management skills
• Understanding of change control processes within a regulated industry
• Experience with project management principles
• Working knowledge of U.S., EU, and international medical device and pharmaceutical regulations
• Experience with electronic quality management systems (e.g., Veeva Vault) preferred
• Ability to collaborate effectively with cross-functional teams, vendors, suppliers, and contract manufacturers

Education & Experience

• Bachelor’s degree in a relevant field (e.g., engineering, life sciences, or related discipline)
• 3–5 years of relevant experience in medical device, pharmaceutical, or combination product environments
• Experience working in a cGMP-regulated environment required
• Experience with medical device development and/or pharmaceutical operations strongly preferred

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.