We are looking to hire an experienced Medical Device Engineer. As the Medical Device Engineer, you play an integral role on project teams working in product development and commercialization, as well as on teams coordinating post-commercialization surveillance, product evolution, and maintenance. In the role, you will also be responsible in assisting in the maintenance and evolution of the Quality Management System. You will utilize various methods to identify, analyze, critique, and correct quality control processes and documented procedures.

In this role you will:

• Formulate or assist in formulating quality assurance policies and procedures
• Gage Design
• Monitor, manage and handle complaints, feedback, and non-conforming products
• Review and approve Document Change orders
• Review and approve Design Control and Risk Management Documentation
• Review and approve drawings and inspection criteria, including Acceptable Quality Limits (AQL)
• Perform risk analyses
• Find, devise, handle, and enforce corrective and preventative actions
• Communicate with engineering and production within an organization and with customers and suppliers on quality-related issues
• Work within the QMS team to ensure the overall quality of manufactured product.
• Devise quality tests and inspections and define the criteria a test or inspection result should meet
• Develop quality control systems
• Analyze quality assurance test results to ensure that the end product meets the needs of the user
• Serve as a Genesis Innovation Group Quality contact with suppliers and participate in weekly supplier meetings
• Ensure Electronic Medical Device Record maintenance of equipment and certificates

To keep up with our fast-paced, detail-driven business qualified candidates will have:

• Bachelor of Science in Engineering or related degree required
• Minimum of 5 years of related experience in a manufacturing environment
• Experience in the medical device industry preferred
• Functioning as a Quality Engineer with experience in problem-solving dimensional inspection techniques and part inspection
• Experience with complaint and CAPA handling a plus
• Audit experience a plus
• Gemoetric Dimensioning and Tolerancing experience a plus
• Ability to work individually and on a team
• Ability to solve quality issues with remote suppliers
• High attention to detail

Genesis Innovation Group (GIG) is a unique Venture Capital and Business Development firm concentrated on medical devices. Our role as investors and industry partners is to focus the creative power of entrepreneurs by leveraging our network, resources, and experience to ensure their success. Combined, we have more than a century of experience in the medical device space, and over two hundred patents and innovations to our names.

Why Join Genesis Innovation Group:

If you are looking to further your career in a pioneering and evolving industry, consider joining our team of professionals. We value and appreciate our employees and will support you with great company culture and opportunities for professional growth. At Genesis Innovation Group, we provide competitive wages, a bonus program, benefits, and strong team collaboration. Apply today for immediate and confidential consideration to become our next Medical Device Engineer. To learn more about us, visit us online at www.genesisinnovationgroup.com.