Description

You will drive the technical direction and product development lifecycle for Acute Therapies medical devices, from feasibility through post-market surveillance.

This role is on-site.

Responsibilities

• Manage product requirements, traceability, and DHF structure maintenance throughout the product lifecycle.
• Translate clinical and user needs into technical specifications and design concepts.
• Execute system integration, verification, and validation activities for medical devices.
• Drive adherence to FDA, ISO, and IEC design control procedures and standards.
• Resolve complex systems issues using root-cause analysis and risk mitigation strategies.

Required Skills

• 10+ years of experience in systems engineering, preferably in medical devices or regulated industries.
• Strong knowledge of electro-mechanical and software system development.
• Proficiency in system modeling languages (SysML or UML) and requirement management.
• Experience with statistical methods for design and verification (e.g., DOE, sample size).
• Ability to influence cross-functional stakeholders and manage multiple projects independently.

Preferred Skills

• Experience with internet-connected, software-enabled devices and cyber security.
• Proficiency with DOORS, Teamcenter, TrackWise8, JIRA, and ALM.

Key Skills

Education

Any Graduate