Job Title: Medical Device Quality Engineer
Location: Maple Grove, MN (Hybrid)
Experience: 3 5 years
We're looking for a Medical Device Quality Engineer to play a key role in ensuring design control, compliance, and product safety for medical electrical equipment and systems. This position requires a balance of technical expertise and quality focus to support product development and lifecycle management.
ResponsibilitiesLead and support design change projects, including scope definition, risk assessment, and implementation.
Develop, maintain, and review documentation such as Design History Files, risk management files, and design input/output records.
Plan, create, and execute verification, validation, and usability protocols in compliance with regulatory standards.
Support investigations and drive resolutions for quality-related issues, including CAPAs, PIRs, and NCEPs.
Bachelor's degree in Mechanical, Electrical, or Biomedical Engineering (preferred).
3 5 years of experience in design quality or engineering roles within the medical device industry.
Strong knowledge of design controls, risk management processes, and relevant medical device standards.
Excellent problem-solving skills with a methodical and analytical mindset.
Strong technical writing and documentation abilities.
Effective communication and collaboration skills across cross-functional teams.
Experience in the cardiovascular field.
Familiarity with FDA, ISO 13485, IEC 60601, and related regulatory standards.