Prinical Systems Engineer, New Product Development

The Principal Systems Engineer provides technical leadership in the definition, architecture, and integration of complex medical devices and systems throughout the full product lifecycle, from concept through commercialization and sustaining support.

Requirements

• Bachelor's Degree in Engineering discipline (Systems, Mechanical, Electrical, or related field).
• Typically 10+ years of experience (or equivalent combination of experience and education)
• In-depth knowledge of medical device development, system engineering principles, and relevant technologies.
• Strong understanding of FDA regulations and international standards for medical devices (ISO 13485, ISO 14971, IEC 60601, IEC 62304).
• Expertise in system integration, interface management, and system verification & validation testing.
• Proven experience conducting risk assessments and implementing mitigation strategies in compliance with ISO 14971.
• Demonstrated ability to lead technical teams, influence stakeholders, and make data-driven technical decisions.
• Strong organizational skills with the ability to manage multiple priorities and deliver results on schedule.
• Proficient in developing and executing comprehensive verification and validation plans.
• Strong self-starter, who is also an effective team player, organized, and must be able to manage multiple projects and meet established timelines.
• Excellent organizational, interpersonal, oral, and written communications skills

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan