Principal Engineer, Systems - Technical Product Lead (Medtech)

TL;DR

Principal Engineer, Systems - Technical Product Lead (Medtech): Architecting and integrating complex medical device systems with an accent on system-level requirements, risk management, and regulatory compliance. Focus on designing safe, compliant architectures and mentoring cross-functional teams through the full product development lifecycle.

Location: Wayne, NJ, US (Hybrid: 1-2 days at home)

Salary: $150,000 - $180,000 + 15% bonus

Company

hirify.global is a global corporation providing hospitals and life science institutions with life-saving technology and workflow optimization solutions.

What you will do

• Define and maintain system architectures, system-level requirements, and interface definitions across hardware, software, and clinical domains.
• Lead system integration, hazard analyses, and risk management in accordance with ISO 14971.
• Oversee verification and validation strategies ensuring compliance with FDA, IEC, ISO, and global regulatory standards.
• Coordinate post-market surveillance, NCRs, and CAPA processes to identify and mitigate product safety and performance issues.
• Provide technical leadership for regulatory submissions (510(k), PMA) and support design reviews and audits.
• Mentor engineers and establish systems engineering best practices and long-term technical roadmaps.

Requirements

• Bachelor’s degree in Engineering with 10+ years of experience (or MS/PhD with 8+ years).
• Minimum 5+ years of experience in medical devices or similarly regulated industries.
• Deep knowledge of FDA Design Controls, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
• Experience with requirements management and modeling tools such as SOLIDWORKS, Polarion, Jama, or SysML.
• Must be based in or able to work from Wayne, NJ (Hybrid setup).

Nice to have

• INCOSE Systems Engineering Certification (ASEP/CSEP).
• Project Management or Risk Management certifications.
• Specialized training in Post-Market Surveillance, CAPA, or Regulatory Compliance.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401k plan with company match.
• Paid Time Off and wellness initiatives.
• Parental and caregiver leave.
• Tuition reimbursement for continued professional development.
• Commuter benefits and flexible spending accounts.