Senior Design Assurance Engineer

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.

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 Senior 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:

• Creates, manages and/or executes test objectives, test plans and schedules. Coordinates test resources for engineering and design verification

• Conducts 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).

• Assists with implementing and maintaining a quality system that is compliant with relevant quality system regulation requirements.

• Provides input to development teams in the design of highly complex medical devices (includes electrical, mechanical, software, drug, IVD). 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.

• Develops, documents, and validates inspection and test methods to support development and manufacturing.

• Supports internal and external audit activities

• Participates in design reviews

• Trains and mentors new and less experienced engineers

Qualifications:

Required skills:

• Bachelor's or Master's degree in quality, engineering or related field

• 4-6 years of relevant work experience in medical devices, or an equivalent combination of education, experience and training

• Expert in ISO13483 and ISO14971. Has experience in ISO10993, IEC60601, IEC62304, IEC62366, MDR and IVDR.

• Strong 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:

• Demonstrated experience with client management

• Experience with different quality management systems

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.

Other details

• Job Family Design Assurance

• Job Function Design Assurance

• Pay Type Salary

• Employment Indicator Regular

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