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Lead System Designer
Lead System DesignerPeer Consulting Resources Inc. • Waukesha, WI, United States
Lead System Designer

Lead System Designer

Peer Consulting Resources Inc. • Waukesha, WI, United States
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Contact Details : 1.Sandeep Bisane

Email : sandeep.bisane@peer-consulting.com

Cell : (732) 802-7361

Job Title : Lead System Designer

Location : Waukesha, WI (onsite)

Duration : 12 Months+

Years of Experience : 8+ Yrs.

Required Hours / Week : 40hrs. / Week

Duties and 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.

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 Required :

  • 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).
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    Lead Designer • Waukesha, WI, United States

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