Senior Systems Engineer – Electromechanical Medical Devices

We are seeking a highly experienced Systems Engineer to serve as a key technical leader supporting the full lifecycle of advanced electromechanical medical device platforms. This individual will play a critical role in architecting, designing, prototyping, and commercializing single-use disposable devices and console systems used in ablation procedures. The role spans concept development through production transfer and post-market support, with strong cross-functional collaboration across marketing, medical affairs, user experience, and engineering teams.

This position requires both strategic systems-level thinking and hands-on execution in a regulated Class II medical device environment.

Location
:
Shoreview, MN

Pay: $85.67 / hr.

Hours: 40 hrs/Week.

Length: Temp to Perm

• Lead system architecture, design, development, and validation of electromechanical medical devices and disposable components.
• Support all phases of new product development, from concept and feasibility through commercialization and post-market activities.
• Develop and refine user and system requirements in partnership with marketing, medical affairs, and user experience teams.
• Conduct and support formative and preclinical studies with physicians and clinical stakeholders to gather user feedback and iterate on designs.
• Architect and design system-level components including electronics, embedded software, mechanical subsystems, and GUI elements.
• Select and evaluate critical components and define system-level specifications.
• Develop system diagrams, requirements documentation, test plans, and V&V documentation.
• Prototype, test, and transfer products to production, including consoles and single-use disposable devices.
• Optimize designs based on validation results and cross-functional feedback.
• Collaborate with external vendors and development partners to accelerate testing and product development.
• Serve as a hands-on technical leader supporting mechanical, electrical, and software engineering teams.
• Contribute to production tooling strategy and test fixture development for Class II medical devices.

• Bachelor's Degree in Electrical or Software.
• Minimum 7 years of experience in electromechanical systems design.
• Minimum 8 years of experience in Electromechanical product development
• Minimum 8 years of experience in System architecture design.
• Minimum 8 years of experience in Critical component selection.
• Minimum 8 years of experience in Prototype, test, and release to production (for single-use disposables and console systems).
• Minimum 8 years of experience in electronics design and system design for new product development.
• Minimum 8 years of experience working with marketing teams to develop user needs and requirements.
• Minimum 8 years of experience in developing software-driven electromechanical medical devices.
• Minimum 8 years of experience in single-use disposable devices.

• Able to work independently without relying on test engineers or technicians.
• Broad engineering expertise across all engineering disciplines.
• Experience with ablation devices.
• Ability to create clear product design documentation, such as concept diagrams, specifications, requirements, test plans, and V&V reports.
• Extensive background in medical device development.
• Proficient in IEC 60601 compliance and standards.
• Skilled in schematic capture and PCB layout using Altium Designer.

Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, Talent Rise, Viaduct) are an Equal Opportunity Employer. Race/Color/Gender/Religion/National Origin/Disability/Veteran.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.