Title: Lead System Designer
Location: Waukesha, WI
Description:
The Lead Systems Designer leads a couple of cross-functional program teams (7T Program and 3T MAGNUS (Head Only Scanner)) Programs to deliver the technical content, performance, intellectual property, and quality deliverables of an NPI and Research programs. The position has design 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. The LSD must understand and capture the user needs into system requirements and is responsible for the architectural decomposition and allocation to subsystems.
Duties include (but are not limited to):
Ensuring that the quality targets are satisfied and retires technical risks as they arise on the program
Leading the design team and design control process from requirements development and design planning to design transfer
Leading the design team in the development of verification and validation planning and execution
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
Driving the architecture, vision and design requirements for the product all the time balancing implementation complexity, risks, manufacturability, serviceability and quality
Quality Specific Goals:
1. Aware of and comply with the Healthcare Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones
5. Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Qualifications:
1. Bachelor's Degree in Engineering/Science or Bachelor's Degree and 2 years experience within technical discipline or equivalent (defined as High School Diploma/GED and 4 years progressive experience as an engineer, scientist within the appropriate field of study or within technical systems designs)
2. 5 years progressive experience as an engineer or scientist within the appropriate field of study
3. 3-year experience in project leadership within a manufacturing, development or research environment
4. Demonstrated experience driving CTQ flow-down to subsystems
5. Demonstrated ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product
6. Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc)
Preferred Qualifications:
1. Masters Degree in Engineering (Mechanical or Electrical)
2. Demonstrated applied 6 Sigma competency
3. Demonstrated experience with NPI ISO and regulatory compliance process, design history file and collaterals are in place and current
4. Creative problem solver and solution developer when presented with conflicting requirements, business demands, and technical risks/issues
5. Demonstrated skills in proactively identifying, facilitating, and driving closure of a product/program
6. Strong interpersonal skills
7. Demonstrated skills in proactively identifying, facilitating, and driving closure of a product/program
8. Familiarity with the HealthCare Quality Manual, Quality Management System, and Quality Goals.
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