Lead System Designer

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 :

Skills Required :