Job Title: Software Quality Engineer Job Description The Design Quality Engineer (DQE) exhibits a robust understanding of engineering principles and practices, applied across various assignments and related fields, all within a collaborative team environment. The DQE will be at the forefront of representing design quality in our organization. This is a pivotal role in shaping quality plans and establishing criteria for diverse products and design activities. This position presents a unique opportunity to make a meaningful contribution to our mission of enhancing patient care through technological advancement. The role is part of an innovative team dedicated to pushing the boundaries of what is possible in medical technology. Responsibilities + Support the Global Quality Management System (QMS) by comprehending its requirements, escalating compliance concerns when needed, and ensuring adherence to regulatory standards. + Ensure completion of CAPA activities including facilitating root cause analysis and leading cross-functional teams for implementation. + Ensure compliance with global QMS procedures - design and development, inclusive of design change control. + Support external QMS inspection and audit. + Demonstrate a strong grasp of both agile and waterfall methods of development. + Ensure alignment with project timelines and design controls deliverables within these frameworks and compliance to regulations and objectives. + Assess and critique the thoroughness and effectiveness of project software testing methodologies. + Support physical devices focusing on quality for embedded software development and testing. + Ensure a comprehensive understanding of hardware and software interactions to identify potential system design failures. + Facilitate and manage risk management activities. + Actively participate in new product development and engage with cross-functional partners in the development phases to develop strategies, risk management activities and verification and validation test strategies. + Propose enhancements to improve design requirements, design implementation traceability, testing accuracy, and software performance. + Identify, document, and track software defects in devices. + Conduct complex or novel research assignments that require the development of new or improved design quality techniques and procedures. + Guide the successful completion of design quality deliverables for major programs; may function in a project leadership role. + Direct one or more major phases of complex engineering work, utilizing engineering skills to devise new approaches to design quality problems encountered in projects. + Mentor less experienced engineers. + Present complex technical information/analysis, responding effectively to questions from technical staff members and management regularly. + Provide statistical analysis support to the design and development team. + Responsible for Test Method Validation activities to support Design Verification Execution. + Stay updated on recent technical advances within the industry and apply this knowledge to products and processes. Essential Skills + 8+ years of experience with ISO 6204. + Experience in software development (testing, developing, quality reviews, etc.) and working knowledge of ISO standards. + Two years of GMP manufacturing experience. + Knowledge and ability to implement GMP practices and FDA regulations. + Knowledge of product development processes including reliability growth, design quality implementation, design controls, statistics, and test method validation. + Driver for acquiring resources and building consensus across products. + Demonstrated skills in technical innovation and technical leadership. + Interactive skills in cross-functional participation and influence, mentoring, technical leadership, and project management. + Ability to communicate effectively both verbally and in writing. + Knowledge and use of relevant PC software applications. Additional Skills & Qualifications + Bachelor’s of Science degree or Master of Science degree in Engineering preferred. Equivalent education and experience sufficient to perform the essential functions of the job may be considered. + Experience representing the organization as the prime design quality technical contact on projects, interacting with senior -level external personnel on significant technical matters requiring coordination between organizations. + Follows and develops technical specification requirements and provides significant input on technical procedures for various processes that impact multiple disciplines. + Knowledge and ability to implement FDA or regulatory requirements as necessary. + Demonstrated ability to solicit and accept the ideas of others while actively contributing to an environment conducive to open communication. Work Environment The work environment involves working within an innovative team dedicated to pushing the boundaries of what is possible in medical technology. The role may require interaction with physical devices and embedded software development and testing. The environment is designed to foster collaboration and continuous improvement, with an emphasis on maintaining adherence to regulatory standards and advancing patient care through technological advancements. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.