GEHC - Lead System Designer I

Notes from manager- Ex- Client healthcare experience is a plus

Title Lead System Designer
Number of Leased Workers needed 1
Tentative start date asap
Tentative end date six months
Work shift (days/times) day shift
Work Location 100% remote, availability from any US time zones
NTE Bill rate ***/hr***(40% max mark-up, do not submit over bill rate listed)
Travel Required (% of travel) no
Is this a temp to perm position contract but could hire on but not guaranteed

Job Overview:
The Client 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 join .....
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 Client's Ultrasound segments.

Essential Responsibilities:
In this role you will:
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. Duties include:
o Leading the design team and design control process from requirements development, design planning to design transfer
o Leading the design team in the development of verification and validation planning and execution for NPIs and released products
o 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 Client's 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 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. Client 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 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 Client's 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
Personal Attributes:

Excellent influencing, interpersonal and communications skills (both written and verbal) with all levels of an organization; able to build good working relationships
Self-starter - requires minimal direction to accomplish goals, proactive and enthusiastic