A Systems Design Quality Engineer is needed for a biomedical/biotechnology engineering firm and multinational manufacturer of medical devices in the Maple Grove, MN (hybrid) area. The role requires ownership of design change projects and involves updating critical documentation such as the Design History File and risk management files.
location: Maple Grove, Minnesota
job type: Contract
salary: $36.40 - 46.47 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Supports the quality assurance of medical electrical equipment in the Interventional Cardiology division.
- Focuses on design changes, material continuity, regulatory compliance, corrective and preventive actions, and product improvements.
- Works within a cross-functional team to ensure product safety, quality, and compliance.
- Has ownership of design change projects, including scoping, assessment, and implementation.
- Develops, updates, and maintains Design History Files and related documentation.
- Updates and maintains risk management files such as FMEAs and Hazard Analyses.
- Develops and executes protocols and reports for Design Verification, Validation, and Usability.
- Provides quality support for resolving PIRs, CAPAs, and NCEPs.
- Applies systematic problem-solving methodologies to identify and resolve quality issues.
- Committed to patient safety and product quality by maintaining compliance with quality policies.
- Experience with design control, risk management, and medical device standards is required.
- Experience with corrective and preventive action is necessary.
- Must be adaptable, a strong collaborator, and capable of self-directed work.
- strong verbal and written communication skills are essential.
- A Bachelor's degree in mechanical, electrical, or biomedical engineering is highly preferred.
- Requires 3-5 years of experience.
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
