Lead System Designer

Payrate: $50.00 - $57.14/hr. Summary: The Ultrasound business consists of ultrasound consoles, handheld ultrasound devices, and ultrasound IT solutions across 5 different market segments. As customers’ needs digital solutions continue to grow, the market for digital ultrasound solutions advances. The Ultrasound Digital organization has a mission to develop a seamlessly connected world of devices and software that creates additional value for customers and patients, beyond devices alone. We aim to grow our offerings via organic as well as inorganic developments. Responsibilities: • Be part of the core program team leading product development programs • It is a responsibility to ensure that product programs achieve all design objectives required to meet customer and business needs, including feature and functionality, quality, reliability, serviceability, manufacture-ability, regulatory, compliance, and cost. • Be responsible for driving the end-of-end product development process from requirements capture to V&V and commercial release. Duties include: • Leading the design team and design control process from requirements development, design planning to design transfer • Leading the design team in the development of verification and validation planning and execution for NPIs and released products • Developing requirements flow down, architecture/system design and analysis, risk analysis, integration and test, manufacturing, field and customer support including corrective and preventative actions to ensure customer satisfaction • Ensure that the quality targets are satisfied and technical risks are addressed as they arise on the program or released product • Aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position • Complete all planned Quality & Compliance training within the defined deadlines • Identify and report any quality or compliance concerns and take immediate corrective action as required • Drive compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones • Identify continuous improvement activities by initiating the implementation of process and product quality improvement initiatives • Responsible for the validation of all GxP relevant applications and maintaining the validated state of those applications • Aware of and comply with the change management work instruction • Develop an open quality culture within the organization that fosters issue discussion and decision-making based on quality and compliance objectives Basic Qualifications: • Bachelor’s degree in computer science or in “STEM” Majors (Science, Technology, Engineering and Math) • A minimum of 8 years of professional experience in software or medical product development, program management, and/or related field, leading cross-functional programs, life-cycle management, and/or large global projects (OR Master’s degree with 6 years of experience) • 2-4 years’ experience in project leadership within an engineering environment. • Demonstrated experience driving requirements development and management and flow-down to subsystems while ensuring traceability between design and test procedures. Requirements: • Master’s degree in computer engineering/computer science or equivalent degree with 8 to 10 years’ experience in industry • Demonstrated experience with New Product Introduction (NPI) regulatory compliance process, design history file and related documentation • Experience with AI development would be an added advantage • Strong knowledge of Phase Review Discipline (PRD) and regulatory process for medical device development • Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues • Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program • Demonstrated ability to balance multiple program priorities while meeting critical commitments • Demonstrated ability to work in a global matrixed organization and deliver results in an ambiguous environment Pay Transparency: The typical base pay for this role across the U.S. is: $50.00 - $57.14/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance. For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacy-policy). 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