Sr Design Assurance Engineer

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 : General Summary

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 the design to manufacturing. Plans and leads execution of risk management on cross-functional product development teams.

Primary Responsibilities

• Leads 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).
• Provides input to development teams in the design of highly complex medical devices.
• Provides quality insight and leadership on program teams and assists with establishing appropriate build quality controls appropriate with use.

Ensures the successful integration of quality assurance and regulatory compliance, working across multiple teams and medical device / equipment categories.

Qualifications : Required skills :

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.