Early Career Biomedical Technician
The Adecco Group
Minneapolis, MN0–2 yrs54m agovia LinkedIn
About the Role
The Associate Engineer is an early career position focused on supporting regulatory compliance and continuous improvement initiatives throughout the product lifecycle. Working closely with cross-functional teams in R&D, Manufacturing, and Regulatory Affairs, you will learn to implement quality tools, investigate non-conformances, and maintain compliance with FDA and ISO standards.
Key Responsibilities
- Testing & Inspection: Assist in developing inspection plans and conducting test methods for raw materials, in-process components, and finished medical devices.
- CAPA & Non-Conformance: Participate in investigating material non-conformances and Root Cause Analysis (RCA); assist in documenting Corrective and Preventive Actions (CAPA).
- Data Analysis: Collect and analyze quality performance data utilizing basic statistical techniques to identify trends and areas for process improvement.
- Quality Assurance & Compliance: Support the maintenance of the Quality Management System (QMS) in accordance with FDA 21 CFR Part 820 and ISO 13485 standards.
- Documentation & Review: Review and update Device History Records (DHR), Standard Operating Procedures (SOPs), and quality inspection logs to ensure complete traceability.
Qualifications & Skills
- Education: Bachelor’s degree in Biomedical Engineering, Bioengineering, Mechanical Engineering, or a closely related technical discipline.
- Experience: Prior internship, co-op, or academic project work within a regulated industry (Medical Device, Pharma, or Biotech) is highly preferred.