Katalyst CRO
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Lead System Designer
role at
Katalyst CRO .
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
Good 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).
Seniority level Associate
Employment type Contract
Job function Engineering and Information Technology
Industries Pharmaceutical Manufacturing
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Lead System Designer
role at
Katalyst CRO .
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
Good 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).
Seniority level Associate
Employment type Contract
Job function Engineering and Information Technology
Industries Pharmaceutical Manufacturing
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