> Markdown version of [/jobs/ext/4014825-design-assurance-engineer](https://www.wearedevelopers.com/jobs/ext/4014825-design-assurance-engineer). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md).

---

# Design Assurance Engineer

- **Company:** Stark Pharma Solutions Inc
- **Location:** Waverly, MN, United States
- **Experience:** Expert
- **Contract:** Temporary to permanent
- **Skills:** Adobe InDesign, Failure Mode Effects Analysis
- **Published:** October 29, 2026
- **Apply:** https://www.careerjet.com/jobad/us0ec8b00e60cbd8962df961ea61afaeed

## About the Role

5+ years of Medical Device Design Quality / Design Assurance experience
Strong Design Controls and Risk Management experience
Design control and/or risk management remediation experience
ISO 13485 and ISO 14971 experience
Test Method Validation and test method development experience
FMEA experience
PDP/NPD experience
Ability to work independently in a highly cross-functional environment
Experience with products such as snares, clips, stents, or similar devices preferred
Desired:
Experience with Nitinol
Experience with Cardiovascular products

## Description

Client seeks an experienced Design Assurance Engineer to support design control and risk management activities within a cardiovascular medical device environment. The role will focus heavily on remediating existing quality documentation while also supporting ongoing product development and lifecycle activities.
Responsibilities:
Review and remediate design control and risk management documentation
Support design inputs/outputs, design verification, and design validation activities
Lead Test Method Validation (TMV) efforts and support test method development
Lead and update FMEAs, hazard analyses, and other risk management documentation
Ensure compliance with ISO 13485, ISO 14971, FDA requirements, and internal quality procedures
Support remediation as well as PDP/NPD activities
Participate in design reviews and other Design Assurance activities
Potentially own or support CAPAs and NCRs
Work autonomously while partnering cross-functionally with Engineering, Quality, Manufacturing, and Regulatory teams