Lead System Designer I
Payrate: $57.00 - $57.14/hr.
Summary:
The primary responsibility of this role is to serve on the program team to deliver successful and timely NPI and ATD programs. In this role, you will work on AI product development, together with a cross-functional team within Caption and across Ultrasound segments.
Responsibilities:
• Be part of the core program team leading product development programs
• Have 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-to-end product development process from requirements capture to V&V and commercial release.
• 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
Quality Specific Goals:
• 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.
Pay Transparency: The typical base pay for this role across the U.S. is: $57.00 - $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).
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 to this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
Payrate: $57.00 - $57.14/hr.
Summary:
The primary responsibility of this role is to serve on the program team to deliver successful and timely NPI and ATD programs. In this role, you will work on AI product development, together with a cross-functional team within Caption and across Ultrasound segments.
Responsibilities:
• Be part of the core program team leading product development programs
• Have 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-to-end product development process from requirements capture to V&V and commercial release.
• 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
Quality Specific Goals:
• 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.
Pay Transparency: The typical base pay for this role across the U.S. is: $57.00 - $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).
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 to this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
