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Job Description

Day to day:

We are seeking a highly skilled Systems Engineer with expertise in mechanical and software engineering to join a leading innovator in the medical device industry. This role focuses on Design History File (DHF) remediation for the SmartDrive MX2+ project, ensuring compliance with regulatory standards while improving product design and functionality. You will leverage your understanding of electromechanical systems, embedded software, and design architecture to manage requirements, risks, and traceability throughout the development lifecycle. This position is ideal for an engineer who thrives in a cross-functional environment and enjoys solving complex technical challenges.

Key Responsibilities:

• Own mapping and definition of high-level architectures, modules, and interfaces for complex electromechanical systems.

• Collaborate with hardware and software SMEs to ensure mapping and definition is clearly articulated and documented supporting agile development.

• Collaborate with Marketing and Medical Affairs to translate user needs into engineering requirements.

• Partner with Product Development to manage risk analysis and implement design controls.

• Draft and maintain high-quality requirement sets for mechanical and software components.

• Define verification strategies and protocols for electromechanical systems and embedded software.

• Ensure traceability across requirements, risks, and test cases throughout the development lifecycle.

• Support DHF remediation activities to meet regulatory and internal quality standards.

• Drive continuous improvement in engineering processes and product reliability.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

• Bachelor’s degree in Mechanical, Electrical, or Software Engineering (or related discipline).

• 5+ years of engineering experience in electromechanical systems or embedded software development.

• Strong understanding of electromechanical systems architecture, including hardware-software integration.

• Familiarity with Agile methodology for iterative development.

• Knowledge of ISO 14971 (Risk Management), ISO 13485 (Quality Systems), and ISO 62304 (Software Lifecycle).

• Ability to write clear, concise, and testable engineering requirements.

• Proficiency in structured problem-solving (FMEA, Root Cause Analysis).

• Skilled in planning, estimating, and tracking technical deliverables.

• Excellent communication skills for cross-functional collaboration with Marketing, Product Development, QA/RA, and Operations. • Experience with electromechanical medical devices (e.g., wheelchairs, mobility systems).

• Familiarity with medical device design controls and regulatory compliance.

• Hands-on experience with embedded systems, control algorithms, or mechanical design tools (e.g., SolidWorks, MATLAB).