Lead System Designer

Quest Global•Waukesha, WI

4d•$100,000 - $120,000•Onsite

About The Position

Quest Global delivers world-class end-to-end engineering solutions by leveraging our deep industry knowledge and digital expertise. By bringing together technologies and industries, alongside the contributions of diverse individuals and their areas of expertise, we are able to solve problems better, faster. This multi-dimensional approach enables us to solve the most critical and large-scale challenges across the aerospace & defense, automotive, energy, hi-tech, healthcare, medical devices, rail and semiconductor industries. We are looking for humble geniuses, who believe that engineering has the potential to make the impossible possible; innovators, who are not only inspired by technology and innovation, but also perpetually driven to design, develop, and test as a trusted partner for Fortune 500 customers. As a team of remarkably diverse engineers, we recognize that what we are really engineering is a brighter future for us all. If you want to contribute to meaningful work and be part of an organization that truly believes when you win, we all win, and when you fail, we all learn, then we're eager to hear from you. The achievers and courageous challenge-crushers we seek, have the following characteristics and skills What You will Do:

Requirements

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).

Nice To Haves

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

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.