Early Career Biomedical Technician

The Adecco Group; Minneapolis (MN); Vor Ort; USD 55.000 - 75.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

401K plan

Paid sick leave

commuter benefits

Zusammenfassung

The Adecco Group seeks an Associate Engineer in Minneapolis to support regulatory compliance and continuous improvement across the product lifecycle. You will collaborate with R&D, Manufacturing, and Regulatory Affairs to implement quality tools, investigate non-conformances, and maintain FDA/ISO compliance.

Ideal candidates hold a bachelor’s degree in a related field and 0–2 years’ experience in regulated environments.

Qualifikationen

• Bachelor's degree in Biomedical Engineering, Bioengineering, Mechanical Engineering, or related technical discipline.
• 0-2 years of experience; internship/co-op in regulated industries preferred.

Aufgaben

• Assist in developing inspection plans and conducting test methods for raw materials, in-process components, and finished medical devices.
• Participate in investigating material non-conformances and Root Cause Analysis; assist in documenting CAPA.
• Collect and analyze quality performance data using basic statistics to identify trends and improvement opportunities.
• Support the maintenance of the Quality Management System (QMS) per FDA 21 CFR Part 820 and ISO 13485.
• Review and update Device History Records (DHR), SOPs, and inspection logs for traceability.

Kenntnisse

Data analysis

Root cause analysis

Quality systems

Ausbildung

Bachelor's degree in Biomedical Engineering

Tools

QMS software

Jobbeschreibung

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: 0-2 years of experience. Prior internship, co-op, or academic project work within a regulated industry (Medical Device, Pharma, or Biotech) is highly preferred.

Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records.