Sr Design Engineer

Medline Industries LP

Base: $101,000.00 - $152,000.00 annual; bonus/equi...
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Solidworks or equivalent 3d cad software proficiency
Minimum 4 years of product design experience
Experience with fda 21 cfr part 820 and iso 13485
** Medline Industries is seeking a Senior Design Engineer to lead product design initiatives for innovative medical devices. The role involves collaborating with cross-functional teams, ensuring regulatory compliance, and mentoring junior engineers. **

Job Summary

  • This role involves leading complex product design initiatives within cross-functional development teams to create innovative medical devices.
  • The position requires ensuring all designs meet regulatory standards including FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
  • Medline Industries offers a competitive total rewards package including health insurance, 401(k) contributions, and paid time off.

Matching Summary

Match Score: 75

** Medline Industries is seeking a Senior Design Engineer to lead product design initiatives for innovative medical devices. The role involves collaborating with cross-functional teams, ensuring regulatory compliance, and mentoring junior engineers. **

Salary

Base: $101,000.00 - $152,000.00 Annual; Bonus/Equity: Bonus and/or incentive eligible; Benefits: Health insurance, life and disability, 401(k), PTO

Skills & Requirements

Must-have

  • SolidWorks or equivalent 3D CAD software proficiency
  • Minimum 4 years of product design experience
  • Experience with FDA 21 CFR Part 820 and ISO 13485
  • Knowledge of design controls and risk management (FMEA)
  • Ability to translate user needs into design specifications

Nice-to-have

  • Certified Solidworks Professional certification
  • Experience launching Class II medical devices
  • Strong intellectual property and patent strategy knowledge
  • Travel up to 10% for domestic and international business
  • Mentoring culture and continuous improvement focus

Key Requirements

  • Bachelor's degree in mechanical, biomedical, or electrical engineering
  • Minimum 4 years of experience in regulated product design
  • Advanced proficiency in SolidWorks and prototype development
  • Experience with design controls, risk management, and DHF/DMR documentation

Work Rights

Not specified

Tailored Resume

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