looking for Lead System Designer

[Sarathy]

We are looking for Lead System Designer at Waukesha, WI

 

Onsite role

 

Healthcare domain must

 

What You will Do:

•                     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.

 

What You Will Bring:

•                     Good Knowledge of GE DHF on both Software and H/W development process is preferable.

•                     System architecture & modeling (SysML, Model-Based Systems Engineering preferred).

 

Skills on:

·         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).

 

 

 

 

 

 

 

 

 

 

 

 

Partha Sarathy Talent Acquisition Lead	E: sar...@rdsolutionsinc.com A: RD Solutions Inc,, Iselin, NJ