Description

You will engineer and manage complex systems within a regulated environment, leading groups to develop solutions for intricate problems.

This role is on-site.

Responsibilities

• Derive and simulate human interactions and device use conditions.
• Manage electronic requirement data and write precise specifications.
• Develop and test products against IEC60601-1 and IEC62336 standards.
• Apply risk management principles per ISO 14971.
• Ensure compliance with US and international regulatory requirements.

Required Skills

• Minimum five years of engineering or R&D experience in a quality-focused environment.
• Minimum three years in a Systems Engineering role or equivalent overall systems responsibility.
• Experience encompassing electrical (analog/digital), mechanical, firmware, and software disciplines.
• Proficiency with electronic requirement data management tools, preferably DOORS.
• Deep knowledge of risk management per ISO 14971.
• In-depth knowledge of US and international regulatory requirements for regulated products.

Preferred Skills

• Ability to build cross-functional and cross-organizational relationships.

Key Skills

Education

Any Gradute