Principal Systems Engineer

Principal Systems Engineer

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented team.

Location(s): Shoreview, MN

Experience Requirements: Minimum Experience: 12+ years. Industry Preference: Medical Devices (strongly preferred). Education: B.S. in Electrical Engineering, Software Engineering, or a related engineering discipline.

Role Overview

The Principal Systems Engineer will serve as a senior technical leader supporting all phases of new medical device platform development-from early concept and technology development through commercialization and post-market support. This role requires deep hands-on expertise in electromechanical system design and the ability to work independently across disciplines without reliance on dedicated test engineers or technicians. The engineer will play a critical role in translating clinical and user needs into robust system architectures and production-ready designs for Class II medical devices, including single-use disposables and console-based systems used in ablation procedures.

Key Responsibilities

• Systems Architecture & Product Development
• Architect, design, develop, test, and transfer to production complex electromechanical systems and disposable devices.
• Define system-level architectures, block diagrams, and interface specifications.
• Select and evaluate critical system components across mechanical, electrical, and software domains.
• Support development of systems incorporating: Touchscreen displays and GUI frameworks. Embedded microcontrollers and application processors. Electronic circuit boards. Sensors, data acquisition systems. Pumps, valves, motors, and RF communications

Hands-On Engineering & Testing

Independently prototype, test, debug, and validate designs. Lead verification and validation (V&V) activities for Class II medical devices. Design test fixtures and support production tooling development. Optimize designs based on test results and risk analysis.

Cross-Functional Collaboration

Partner closely with Marketing, Medical Affairs, and UX teams to: Develop and refine user needs and design inputs. Support preclinical and formative studies with physicians and clinical staff. Incorporate user feedback into iterative design improvements. Work directly with physicians and clinical teams during formative evaluations. Collaborate with mechanical, electrical, and software engineers to drive integrated solutions.

Documentation & Compliance

Create and maintain high-quality product development documentation, including: System and concept diagrams. Design specifications and requirements. Test plans, protocols, and V&V reports. Support requirements management and traceability throughout the product lifecycle

Vendor & Partner Engagement

Coordinate with external vendors and development partners to accelerate prototyping and testing. Provide technical oversight and integration support for outsourced components or subsystems.

Required Technical Skills & Tools

Electromechanical product development (end-to-end). System architecture design. Critical component selection and evaluation. Prototype-to-production experience (single-use disposables and console systems). Hands-on, self-sufficient engineering capability. Tools & Platforms JAMA - Requirements management. Altium - Electrical design. SolidWorks - Mechanical design

Preferred Experience

Software-driven electromechanical medical devices. Ablation systems and energy-based therapeutic devices. Single-use disposable medical devices. Broad, cross-disciplinary engineering background (mechanical, electrical, software)

Travel: Quarterly travel to Austin, TX (approximately once per quarter).

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.