Description

You will own the systems engineering lifecycle for medical device products, from new product development through post-market surveillance.

This role is on-site.

Responsibilities

• Capture and translate user needs, regulatory standards, and quality inputs into clear product requirements.
• Create and maintain design history file elements while driving design concepts from a systems perspective.
• Anticipate technical risks, execute mitigation strategies, and resolve ambiguous systems-related issues using root-cause analysis.
• Perform impact assessments on design, material, or process changes and propose recommended mitigations with rationale.
• Drive adherence to FDA, ISO, and IEC design control procedures and influence cross-functional stakeholders.

Required Skills

• 5+ years of experience in systems engineering, preferably within medical devices (ICU or kidney care domains).
• Track record in electro-mechanical system development in regulated industries such as aerospace, automotive, or military.
• Experience with internet-connected, software-enabled devices and understanding of cybersecurity principles.
• Proficiency in system modeling languages (SysML or UML) and requirement management tools.
• Knowledge of statistical methods for design and verification, including DOE and sample size calculations.
• Familiarity with JIRA, Teamcenter, and TrackWise.
• Bachelor’s or Master’s degree in Electrical, Software, Mechanical, Biomedical, or related engineering/science discipline.

Key Skills

Education

Bachelor's or Master's degrees