Auris is a technology company defining the future of medical intervention. By combining advancements in medical robotics, instrumentation, navigation and data science, Auris is building a platform technology capable of expanding the applicability of robotics to a spectrum of medical procedures.
The Quality Engineering Manager will be responsible for overseeing a team of quality engineers to provide quality engineering support for product development. The ideal candidate should have experience in managing a team of Quality Engineer supporting product development of complex electro-mechanical, software-controlled systems for medical applications to ensure robust product design that enable delivery of compliant, high-quality product to the customers. This individual will work with various engineering teams within the company like R&D and Manufacturing Operation, as well as other functions like Procurement, Regulatory Affairs, and so on.
Core Job Responsibilities:
- Provide guidance and leadership to the Quality Engineers for the application of internal development procedures within the framework of regulatory requirements.
- Provide guidance and mentoring to Quality Engineers and other product development team members in the areas of Quality Engineering which consists of Reliability Engineering, Risk Management, Design Control, Statistics, Test Method Validation (MSA), Software Quality, and Process Validation.
- Interact and form constructive working relationships with all levels of leadership within Quality, Research & Development, Regulatory and Operations organization.
- Develop and manage a team of quality engineer including recruiting, mentoring, and helping to improve employee performance in order to have an engaged and productive workforce. Deploys and utilizes staff across a wide variety of research, product concept, and development activities.
- Utilize coaching and facilitating skills with program/project shareholders to ensure expectation setting and best practices are utilized.
- Provide training to other functional area team members on Design Control and Application of Risk Management as Design for Quality and Reliability Tool.
- Ensure the adequacy of design quality, including documentation and other supporting quality evidence such that the Design Documentation is in audit ready state
- Support the Risk Management Process per ISO 14971 and provide leadership in utilizing ISO14971 Hazard Analysis as a Design for Quality tool to develop proper Design Input to ensure device safety
- Provide guidance on the principles of IEC standards like IEC 60601 and IEC 62304 as they relate to the new product development activities of electromechanical medical devices.
- Provide guidance and leadership to plans and methods for design verification & validation testing, including regression testing.
- Provide leadership in applying reliability demonstration method to be used as Design Verification test method as appropriate
- Utilize knowledge in statistical analyses to collaborate with Engineering team on the optimal approach for analyzing test data and determining Pass/Fail criteria, sample size determination and other applications requiring statistical knowledge
- Assist in various projects and other duties as assigned.
- Education and/or experience equivalent to a bachelor's degree in Science or Engineering, or a related field with minimum of 15 years of quality engineering or R&D experience.
- This position requires knowledge of medical device regulatory environment (FDA, MDD, ISO 13485). Candidates should also have knowledge and experience to support product development per QSR design control requirements, testing requirements like TMV and test protocol development, and risk management per ISO 14971 and other standards like IEC60812 and AIAG.
- Preferred experience with complex electro-mechanical device with embedded software, capital equipment, and consumable devices.
- Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member as well as in leadership role
- Proven ability to work effectively in a team environment through conflict resolution and negotiations.
- Advanced analytical and problem-solving skills. Reliability Engineering skill set is highly preferred
- Minimum of 5 years in engineering management.
- Ability to guide and mentor on Use of Statistical Sampling Methods and general statistics
- Prior experience working in a regulated environment compliant to ISO 13485 and 21 CFR 820.
- Travel estimate: approximately up to 20%