Sustaining Systems Design Quality Engineer

Maple Grove, MN - USA

Monthly Salary: Not Disclosed

Posted on: 22-08-2025

Vacancies: 1 Vacancy

Job Summary

Responsibilities:

Ownership of design change projects including scoping assessment and implementation.
Develop update and maintain Design History File and Design Input / Output documentation.
Update and maintain risk management files such as the Hazard Analysis Task Analysis and Design FMEA.
Develop and execute Design Verification Design Validation and Usability protocols and reports to meet or exceed internal and external requirements.
Provide design quality support in the resolution of PIRs CAPAs and NCEPs.
Apply sound systematic problem-solving methodologies in identifying prioritizing communicating and resolving quality issues.
Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Requirements:

3-5 Years with BS. Degree must be clearly stated on resume.
Bachelors degree in mechanical electrical or biomedical engineering highly preferred.
Experience with design control risk management and medical device standards compliance.
Experience with corrective and preventive action.
Adaptable and effective collaborator in a team environment and in self-directed work.
Strong communication skills.

Responsibilities: Ownership of design change projects including scoping assessment and implementation. Develop update and maintain Design History File and Design Input / Output documentation. Update and maintain risk management files such as the Hazard Analysis Task Analysis and Design FMEA. Develo...