Lead System DesignerKatalyst CRO • Waukesha, WI, US
Lead System Designer
Katalyst CRO • Waukesha, WI, US
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job_description.job_card.job_descriptionGood knowledge of client DHF on both software and H / W development processes. System architecture and modeling (SysML, model-based systems engineering). 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, and FDA design control requirements (21 CFR 820.30).
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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).
- 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 (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.
- Conduct design reviews (PDR, CDR, TRR).
Requirements
Seniority level
Associate
Employment type
Contract
Job function
Engineering and Information Technology
Industries
Pharmaceutical Manufacturing
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Lead Designer • Waukesha, WI, US