Description

You will lead systems engineering activities across the product lifecycle, from new product development through post-market surveillance.

This role is hybrid.

Responsibilities

• Capture and translate clinical, user, and regulatory requirements into product realization strategies.
• Create and maintain Design History File (DHF) elements while ensuring adherence to FDA, ISO, and IEC design control procedures.
• Anticipate technical challenges and lead mitigation strategies using tools like cause-and-effect diagrams and Pareto charts.
• Perform impact assessments for design, material, or process changes and propose recommended mitigations.
• Influence cross-functional stakeholders to drive solutions for ambiguous, diverse technical problems.

Required Skills

• 8+ years of experience in systems engineering, with a track record in electro-mechanical system development.
• Strong knowledge of software engineering and systems modeling languages (SysML or UML).
• Proficiency with requirement management and ALM tools: DOORS, Teamcenter, TrackWise8, JIRA.
• Experience in regulated industries, preferably medical devices (ICU or kidney care domains preferred).
• Familiarity with internet-connected, software-enabled devices and cybersecurity principles.
• Working knowledge of statistical methods for design and verification, such as DOE and sample size calculations.
• Bachelor's or Master's degree in electrical, software, mechanical, biomedical engineering, or a related science discipline.

Key Skills

Education

Bachelor's or Master's degrees