Sr Design Assurance Engineer

Veranex; Minneapolis, Northern (MN, KY); Hybrid; USD 100,000 - 140,000; Full time

Job summary

Veranex is seeking a Senior Design Assurance Engineer in Minneapolis, MN, to join our medical device quality team and help ensure regulatory compliance across product development.

You will lead risk management, support design transfer to manufacturing, and work with cross-functional teams to uphold design history file documentation and the Quality System in line with ISO 13485, FDA QSRs, and MDR/IVDR requirements.

Qualifications

• Bachelor’s degree in engineering or related field is required.
• 3–6 years of relevant work experience in medical devices.
• Knowledge of ISO 13485 and ISO 14971.
• Familiarity with FDA QSRs, MDR/IVDR, and ISO147-?

Responsibilities

• Lead risk management for medical devices, including risk management plans and reports, hazard analyses and FMEA.
• Plan, develop, and execute verification and validation testing for products in development.
• Provide input to design teams for highly complex devices and establish appropriate build quality controls.
• Develop, document, and validate inspection and test methods to support development and manufacturing.
• Participate in the technical review of design input specifications and design documentation.
• Implement and maintain a quality system compliant with regulatory requirements; participate in QA system improvements.
• Ensure integration of quality assurance and regulatory compliance across multiple teams.
• Support internal and external audit activities.
• Train and mentor new and less experienced engineers.

Skills

Strong communication

Attention to detail

Client management

Quality systems knowledge

Education

Bachelor’s degree in engineering or related field

Job description

Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.

About This Role

Veranex has an exciting opportunity to join our team as a Senior Design Assurance Engineer. You will be part of a team working to improve lives globally through medical technology innovation. The Design Assurance Engineer is responsible for accurate, independent generation and evaluation of risk management, design history file documentation and overall quality system compliance. Ensures compliance to customer and regulatory requirements and assists with the successful transfer of design to manufacturing. Plans and leads execution of risk management on cross-functional product development teams.

What You Will Do

• Lead risk management for novel and existing medical devices, including risk management plans and reports, hazard analyses and use, design, and process Failure Mode & Effects Analysis (FMEA).
• Plans, develops, and executes verification and validation testing for products under development.
• Provides input to development teams in the design of highly complex medical devices (including electrical, mechanical, software, drug, IVD). Provides quality insight and leadership on program teams and assists with establishing appropriate build quality controls appropriate with use.
• Develops, documents, and validates inspection and test methods to support development and manufacturing.
• Participate in the technical review of design input specifications and design documentation for new medical devices.
• Assists with implementing and maintaining a quality system that is compliant with relevant quality system regulation requirements.Participate in Quality System continuous improvement activities.
• Ensures the successful integration of quality assurance and regulatory compliance, working across multiple teams and medical device/equipment categories.
• Supports internal and external audit activities.
• Trains and mentors new and less experienced engineers. May provide performance feedback on performance of peers to functional management.

Required Qualifications

• Bachelor’s degree in engineering or related field
• 3-6 years of relevant work experience in medical devices, or an equivalent combination of education, experience and training
• Working understanding of ISO 13483 and ISO 14971.
• Has experience in ISO10993, IEC60601, IEC62304, IEC62366, MDR and IVDR.
• Working understanding of Food & Drug Administration (FDA) Quality System regulations, European Active Implantable & Medical Device Regulations, and relevant medical device principles
• Excellent written and oral communication skills
• Excellent attention to detail

Preferred Qualifications

• Demonstrated experience with client management
• Experience with different quality management systems

Location

• This is an onsite position in Minneapolis, MN

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics. Applicants must be currently authorized to work in the United States on a full-time basis. The company is not able to sponsor visas or provide employment-based immigration sponsorship for this role now or in the future.