Lead System Designer

Job Title: Lead System Designer
Work Location: Wauwatosa, WI (100% remote, availability from any US time zones)
Duration: 6 months+ (contract to Hire)
 
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 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:
  • 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 client 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 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.