Pittsburgh Robotics Network · 1 day ago
Sr. Quality Engineer
Pittsburgh Robotics Network is seeking a Sr. Quality Engineer to serve as the primary quality representative in hardware development. The role involves collaboration with engineering, product management, and operations to ensure quality is integrated into the product and compliance with regulatory standards.
Artificial Intelligence (AI)AssociationNon ProfitRobotics
Responsibilities
Serve as the primary quality representative in the development of hardware collaborating with engineering, product management, and operations to ensure quality is embedded into the product
Ensure hardware development is aligned with the holistic product offering including system engineering strategies and software interfaces
Liaise with Regulatory and other Quality departments throughout the product development process for necessary inputs into development
Work with safety risk management and the supporting team to create a risk file during the development of the product and ensure the incorporation of appropriate design mitigations
Review and approve verification and validation protocols, and final design outputs, ensuring consistency with quality, regulatory and safety standards
Support design transfer activities to ensure product specifications and quality requirements are effectively communicated to manufacturing and supply chain teams
Champion continuous improvement initiatives, identifying opportunities to enhance product quality and optimize internal processes
Implement quality metrics and drive actions to meet key performance indicators (KPIs)
Support post-market surveillance activities including complaint trending, defect management and field issue resolution
Qualification
Required
Bachelor's degree in Engineering or Science discipline
3-4 years professional experience
Experience in product development
5+ years professional experience
Experience in process development
Experience working with medical devices (i.e. ISO 13485 or FDA regulated)
Knowledge of QMS processes and regulatory standards (ISO 9001 or 13485)
Demonstrated ability to lead large-scale quality projects, including product development and risk mitigation
Strong leadership and decision-making skills, with the ability to influence cross-functional teams and senior leadership
Experience working with hardware engineers and electro-mechanical systems
Exceptional technical communication skills
Company
Pittsburgh Robotics Network
An organization dedicated to the growth and promotion of Pittsburgh's robotics companies and research institutions
Funding
Current Stage
Early StageTotal Funding
$0.75MKey Investors
Appalachian Regional Commission
2024-10-16Grant· $0.75M
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