Senior Design Quality Engineer – Medical Devices

ECI; Arden Hills (MN); On-site; USD 85,000 - 120,000; Full time

Job summary

ECI in Arden Hills, MN seeks a Design Quality Assurance Engineer to ensure the Product Lifecycle, Risk Management, Design Controls, and Usability Testing meet requirements within fast-paced cross-functional teams.

You'll support risk planning, QA processes, design reviews, V&V, post-market activities, and audits, while maintaining DHFs and delivering robust quality metrics for medical devices.

Qualifications

• Bachelor’s Degree in Biomedical/ Mechanical/ electrical engineering or equivalent is required.
• Minimum of 5 years direct experience in medical device industry preferred.
• Ability to perform work accurately and thoroughly.
• Ability to communicate effectively in written and oral form.
• Excellent report writing skills essential along with the ability to find a solution or deal proactively with work related problems.
• Ability to develop and sustain positive relationships with internal as well as external customers.
• Good analytical and problem-solving skills.
• Broad and in depth regulatory knowledge in medical device (Class II and III medical devices).
• Vast experience in writing/reviewing design control documents and compilation of DHFs.
• Experience with Minitab Statistical software.

Responsibilities

• Provide quality and compliance input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling)
• Support Risk Management planning, updating and maintenance of the product risk documentation in compliance with regulatory standards
• Support Usability Engineering and planning documentation
• Support the implementation of effective quality assurance, process controls, statistical analyses, and metrics
• Provide key quality trending information and data
• Offer quality and compliance input for post-market activities such as design changes, supplier auditing, and customer complaint investigations
• Identify, prioritize, communicate, and resolve quality issues
• Lead implementation activities for post-market surveillance, product feedback, and corrective and preventive action programs
• Support internal and external audits

Skills

Quality assurance

Regulatory knowledge

Design controls

Risk management

Statistical analysis

Communication skills

Documentation writing

DHFs compilation

Minitab

Education

Bachelor’s Degree in Biomedical/Mechanical/Electrical engineering

Tools

Minitab

Job description

ECI in Arden Hills, MN seeks a Design Quality Assurance Engineer to ensure the Product Lifecycle, Risk Management, Design Controls, and Usability Testing meet requirements within fast-paced cross-functional teams.

You'll support risk planning, QA processes, design reviews, V&V, post-market activities, and audits, while maintaining DHFs and delivering robust quality metrics for medical devices.