Principal Design Quality Engineer - Medical Device #7324

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

About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About The Role

As a Design Quality Assurance Engineer, you will ensure that all requirements are met for the Product Lifecycle Process, Risk Management, Design Controls, and Usability Testing. You will work in fast-paced cross-functional teams to maintain and support quality-engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements.

What You’ll Do

• 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

What You’ll Bring

• 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

Equal Opportunity Employer Statement

ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.