Senior Design Assurance Engineer
Apply NowCompany: Veranex
Location: Providence, RI 02902
Description:
Veranex is the leading service provider for medtech companies. Our global team of experts help clients anticipate challenges and find solutions throughout the development and commercial lifecycle. Together, we accelerate new technologies to market and improve patient outcomes.
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:
Qualifications:
Required skills:
Preferred:
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.
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 ISO13485 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.