Principal System Engineer

Hollister Incorporated

Libertyville, IL, US
Base: $140,000 - $191,000 yearly; bonus/equity: el...
On-site
Systems engineering leadership
Requirements engineering and management
Medical device risk management
The Principal Systems Engineer leads technical efforts to develop new medical device products from concept through commercialization, ensuring safe, effective, and compliant products are delivered on time and within budget

Job Summary

  • The Principal Systems Engineer leads technical efforts to develop new medical device products from concept through commercialization, ensuring safe, effective, and compliant products are delivered on time and within budget.
  • The role involves collaboration across mechanical, electrical, software, quality, regulatory, and manufacturing functions to define requirements, develop system architectures, perform risk analysis, and drive system verification and validation.
  • Hollister Incorporated offers a competitive total rewards package including above market pay, health and life insurance, wellness programs, retirement savings, paid time off, and opportunities for professional development.

Matching Summary

The Principal Systems Engineer leads technical efforts to develop new medical device products from concept through commercialization, ensuring safe, effective, and compliant products are delivered on time and within budget.

Salary

Base: $140,000 - $191,000 yearly; Bonus/Equity: Eligible for Hollister Corporate Bonus Plan; Benefits: Health, life insurance, wellness programs, retirement savings, paid time off

Skills & Requirements

Must-have

  • Systems engineering leadership
  • Requirements engineering and management
  • Medical device risk management
  • Model-based systems engineering (MBSE)
  • Cross-functional team collaboration
  • Design control compliance
  • Verification and validation strategy

Nice-to-have

  • Mentoring and coaching engineers
  • Effective negotiation and facilitation
  • Strong communication skills
  • Proactive decision-making
  • Experience with FDA and ISO standards

Key Requirements

  • 10+ years engineering experience in regulated product development
  • 8+ years medical device industry experience
  • 6+ years applying risk management methodologies per ISO 14971
  • Experience leading design control activities
  • B.S., M.S., or Ph.D. in Engineering with relevant experience
  • INCOSE CSEP or ESEP certification preferred
  • ISO 13485 Lead Auditor certification preferred
  • Travel up to 25% required

Work Rights

Not specified

Tailored Resume

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