Sr Design QA Engineer

Are you a Design QA Engineer looking for a position with a strong company, where a variety of projects come your way! If you are, this position is definitely one you want to apply for. This exciting position is working with Minnetronix Medical and is a direct hire position. In this position, you would maintain quality systems, including compliance with FDA Design Controls and ISO 13485 requirements to support product clearance/approvals/licenses, and qualifications of quality systems. Design QA Engineers work with design teams to ensure that devices are designed in accordance with the product requirements and that they meet their intended use. They will review requirements, specifications and technical design documents to provide timely and meaningful feedback aimed at improving product quality, safety, reliability, and manufacturability and ultimately ensure customer satisfaction. The Senior Design QA Engineers have an extensive/broad knowledge of all aspects of the medical device product development and lifecycle processes, Will use creativity to solve complex issues and manage project planning. They have demonstrated leadership and communication skills and contribute to customer confidence and satisfaction. Additionally, they may supervise a team of engineers and technicians. Mentor less experienced QA engineers and support the Minnetronix sales team.   Would also apply knowledge of applicable industry standard to product development processes, e.g. ISO 14971 Rise Management Standard, IEC 60601-1 Medical Electrical Equipment and collateral standards, IEC 62366 Usability Standard, and IEC 62304 Software Lifecycle Processes Standard. What are we looking for?   Someone who has…BS/MS in Biomedical, Electrical, Mechanical or Computer Engineering or equivalent experience. Requires a minimum of 6 years of design control and quality assurance experience in the development of medical devices involving a combination of electronic, software and mechanical designs. Requirements a minimum of 5 years’ experience in development and management of design history files, technical files, and design dossiers.Statistical expertise to support sample size and reliability prediction.Must have leadership/supervisory experience as “lead” on projects of high complexity.Strong interpersonal, teamwork and communication skills. Must have demonstrated experience with internal/external customers to build confidence and satisfaction.Strong written communication demonstrating the ability to simplify complex information.Familiarity with standard laboratory equipment and capable of reading electrical schematics, component datasheets, and assembly drawings. The person must be authorized to work in the US. Our company offers excellent benefits including medical, dental, life and disability insurances, 401K plan, paid time off, and tuition reimbursement among others. Additionally, Minnetronix Medical has a fun flexible and challenging work environment that fosters innovation and growth for all employees.  Please apply at We Make it Easy• Applying takes less than 2 minutes. No passwords or accounts to register or sign-in for.• You are hired directly by the company – MRA does not make hiring decisions.MRA is a not-for-profit employers association serving over 4,000 companies throughout the upper Midwest. We partner with these companies working directly with their HR department and leadership to hire their talent. We are a direct line to the company, not an agency recruiter.

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