Katalyst CRO ยท 2 months ago
Lead System Designer
Waukesha, WI
Contract
Onsite
Lead/StaffKatalyst CRO is seeking a Lead System Designer to develop system architecture and ensure integration integrity based on user needs and functional requirements. The role involves leading cross-functional teams, conducting design reviews, and mentoring junior engineers while ensuring compliance with applicable standards and regulations.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop the system architecture based on user needs, functional requirements, and design inputs
Decompose high-level requirements into subsystem and component-level specifications
Lead trade-off studies (performance, cost, reliability, manufacturability)
Define interfaces (mechanical, electrical, software) and ensure system integration integrity
Guide cross-functional teams (hardware, firmware, mechanical, and software)
Conduct design reviews (PDR, CDR, TRR)
Mentor junior engineers and foster systems thinking across the team
Own requirements management traceability from user needs to verification results
Identify technical risks and lead mitigations throughout the lifecycle
Ensure design complies with applicable standards and regulations (e.g., ISO 13485, IEC 60601, ISO 14971)
Define and oversee system verification plans and test strategies
Support V&V activities and integration testing
Ensure the design satisfies all intended use and regulatory requirements
Interface with product management, quality, manufacturing, and supply chain teams
Support design transfer to manufacturing and post-market design changes
Collaborate with suppliers for system-level components and integration
Qualification
Required
Good Knowledge of Client DHF on both Software and H/W development process is preferable
System architecture & modeling (SysML, Model-Based Systems Engineering preferred)
Requirements management tools (e.g., IBM DOORS, Jama, Polarion)
Familiarity with embedded systems, analog/digital design, and mechanical integration
Design for reliability, manufacturability, and serviceability
FMEA, FTA, and risk-based design principles
Strong technical leadership across diverse disciplines
Excellent documentation and communication skills for cross-functional alignment
Decision-making under uncertainty and trade-off evaluation
Regulatory compliance alignment knowledge including ISO 13485, IEC 60601, ISO 14971, IEC 62304 (software), IEC 61010. Understanding of FDA design control requirements (21 CFR 820.30)
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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