Genesis Innovation Group

Engineer

• Travel up to 40% of the time
• Manage projects from initial concept through to production, ensuring timely completion and adherence to project goals
• Regularly interact with surgeon customers to discuss product improvements and new instrument ideas
• Coordinate with cross-functional teams to ensure technical and creative alignment
• Create project plan including assigning tasks to team members
• Monitor and review work of team members to ensure high quality work
• Manage project budgets, ensuring effective allocation of financial resources
• Monitor expenditures and adjust as necessary
• Own the regulatory clearance planning and strategy pathway to be approved by the team lead
• Maintain documentation for regulatory submissions and quality management systems
• Lead the design and development of medical and surgical components, equipment, and instruments
• Understand and make well-reasoned design decisions and tradeoffs in their area
• Create and modify detailed CAD models and technical drawings
• Deliver complex products to test labs
• Conduct tests to evaluate product performance, safety, and functionality
• Troubleshoot and resolve any issues that arise during the testing phase
• Evaluate negative or questionable test results and advises team on impact and solutions
• Build and maintain strong relationships with surgeons, clients, and suppliers
• Actively seek and incorporate feedback from stakeholders into the design and development process
• Participate in continuous improvement initiatives to enhance product quality and development processes
• Provide technical advice and weighs in on technical decisions that impact other teams or the company at large

Senior Medical Development Engineer

QA Engineer

• Identify, analyze, critique, and correct quality control processes and documented procedures
• Interact with a variety of suppliers and the Genesis family of companies to ensure consistency, accuracy, and the implementation of best practices
• Formulate or help formulate quality assurance policies and procedures
• Review and provide input to design plans, user requirements, design inputs, test procedures, risk management file, and design outputs to understand the scope, requirements, and function of the systems
• Ensure that products meet the organizations and customers’ quality and product integrity requirements
• Support the product development team by providing analysis and expertise throughout the inspection process
• Identify root causes of problems in the production process; recommend and/or implements corrective measures
• Analyze data to identify trends in product quality or defects with a goal of mitigating and preventing recurrence and future defects
• Ensure manufacturing processes comply with federal, state, local, and industry standards and regulations
• Perform risk analysis as part of the risk management team
• Perform gap analyses on standards and regulations as new customers are brought onboard and as new or revised standards are released
• Conduct training on quality assurance concepts and tools
• Monitor, manage and handle complaints, feedback, and non-conforming products
• Find, devise, handle, and enforce corrective and preventative actions
• Communicate with engineering and productions within an organization and with customers and suppliers on quality-related issues
• Work within the QMS team to ensure the overall quality of a manufactured product
• Create, support, and oversee documentation
• Develop quality control systems
• Analyze quality assurance test results to ensure that the end product meets the exact needs of the user

Senior Medical Development Engineer

Senior Quality Engineer