Lead System Designer - Aditi Consulting

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

• 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.

• 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

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 ().

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.

#AditiConsulting #25-22175

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.