MARS Solutions Group is looking for an experienced Lead System Designer, for a client located in Wauwatosa WI, USA. Our client is a well-known Healthcare industry and organization seeking bright, tech-savvy talent.Client Industry: Healthcare IndustryLocation: Wauwatosa WI, USAJob Type: 100% Remote, availability from any US time zonesJob Title: Lead System DesignerExperience Level: 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)Nice to Have Skills: 2-4 years experience in project leadership within engineering environment.Schedule/Hours: 1st Shift M-FEssential Responsibilities:The HealthCare 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.We are looking for an experienced LSD to joinThe 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 GEHC Ultrasound segments.Essential Responsibilities:Be part of the core program team leading product development programsHave 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. Duties include:Leading the design team and design control process from requirements development, design planning to design transferLeading the design team in the development of verification and validation planning and execution for NPIs and released productsDeveloping 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 satisfactionEnsure that the quality targets are satisfied and technical risks are addressed as they arise on the program or released productQuality 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/positionComplete all planned Quality & Compliance training within the defined deadlinesIdentify and report any quality or compliance concerns and take immediate corrective action as requiredDrive compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestonesIdentify continuous improvement activities by initiating the implementation of process and product quality improvement initiativesResponsible for the validation of all GxP relevant applications and maintaining the validated state of those applicationsAware of and comply with the change management work instructionDevelop an open quality culture within the organization that fosters issue discussion and decision-making based on quality and compliance objectivesBasic 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 engineering environment.Demonstrated experience driving requirements development and management and flow-down to subsystems while ensuring traceability between design and test procedures.Eligibility Requirements:This position is based in the United States only. Legal authorization to work in the U.S. is required. GE HealthCare may agree to sponsor an individual for an employment visa now or in the future if there is a shortage of individuals with particular skills.Must be willing to travel as required.Desired Characteristics:Master s Degree in Computer Engineering/Computer Science or equivalent degree with 8 to 10 years experience in industryDemonstrated experience with New Product Introduction (NPI) regulatory compliance process, design history file and related documentationExperience with AI development would be an added advantageStrong knowledge of GEHC Phase Review Discipline (PRD) and regulatory process for medical device developmentCreative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issuesDemonstrated skills in proactively identifying, facilitating and driving closure of a product/programDemonstrated ability to balance multiple program priorities while meeting critical commitmentsDemonstrated ability to work in a global matrixed organization and deliver results in an ambiguous environmentPersonal Attributes:Excellent influencing, interpersonal and communications skills (both written and verbal) with all levels of an organization; able to build good working relationshipsSelf-starter - requires minimal direction to accomplish goals, proactive and enthusiasticAbout MARS Solutions Group: MARS Solutions Group is an IT staffing firm with access to a wide variety of jobs at various clients across the country. We operate with the consultant's best interests in mind and align them with roles that match their skills, aspirations, and interests. MARS values our relationships with consultants. Therefore, we will stay in touch throughout the duration of the contract to ensure the job is going well and that the role meets their career development needs.
