Katalyst CRO · 2 months ago
Lead System Designer
Waukesha, WI
Contract
Onsite
Senior Level, Lead/Staff
5+ years expKatalyst CRO is seeking a Lead System Designer to oversee cross-functional program teams responsible for delivering technical content and quality deliverables for NPI and Research programs. The role involves ensuring design objectives are met, leading design teams, and managing system requirements to satisfy customer and business needs.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
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
Qualification
Required
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)
5 years progressive experience as an engineer or scientist within the appropriate field of study
3-year experience in project leadership within a manufacturing, development or research environment
Demonstrated experience driving CTQ flow-down to subsystems
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
Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc)
Aware of and comply with the GEHC 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
Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones
Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Preferred
Master's degree in engineering (Mechanical or Electrical)
Demonstrated applied 6 Sigma competency
Demonstrated experience with NPI ISO and regulatory compliance process, design history file and collaterals are in place and current
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
Strong interpersonal skills
Familiarity with the Client HealthCare Quality Manual, Quality Management System, and Quality Goals
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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