Senior Design Assurance Engineer - Medical device
Job in
Plymouth, Hennepin County, Minnesota, USA
Listed on 2026-07-14
Listing for:
Intellectt Inc
Seasonal/Temporary
position Listed on 2026-07-14
Job specializations:
-
Engineering
Quality Engineering, Regulatory Compliance Specialist, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Job Title:
Senior Design Assurance Engineer - Medical device
Location:
Maple Grove, MN (Hybrid)
Duration: 12 Months Contract
Job Summary:
We are seeking a Senior Design Assurance Engineer with 10+ years of experience in the medical device industry. The ideal candidate will provide hands-on quality engineering support for product development, ensuring compliance with FDA regulations, ISO standards, and Design Control requirements throughout the product lifecycle.
Key Responsibilities:
- Support Design Assurance activities for new product development.
- Develop, implement, and maintain Quality Engineering processes and methodologies.
- Review and support Design Controls, Design Matrices, and Engineering Prints.
- Prepare, review, and maintain Design History File (DHF) documentation.
- Perform risk management activities in accordance with ISO 14971.
- Participate in ISO standards gap assessments and remediation projects.
- Collaborate with R&D, Manufacturing, Quality, and Regulatory teams to ensure product compliance.
- Ensure products meet FDA, ISO, customer, and internal quality requirements.
- Drive continuous quality improvements and support quality initiatives across cross-functional teams.
Required Qualifications:
- Bachelor's degree in Engineering or a related technical field.
- 10+ years of Design Assurance or Quality Engineering experience in the Medical Device industry.
- Strong hands‑on experience with:
Design Controls, Design Matrices & Engineering Prints, Design Verification & Validation (V&V), Design History File (DHF), ISO 14971 Risk Management, FDA Design Control requirements - Experience supporting ISO standards gap assessment or remediation projects.
- Strong understanding of Quality Engineering principles within regulated medical device environments.
- Excellent communication and cross‑functional collaboration skills.
Preferred
Skills:
- Experience supporting new product development (NPD).
- Knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
Position Requirements
10+ Years
work experience
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×