Senior Design Assurance Engineer

OnboardNWA

Base: $120,450 - $176,660; bonus/equity: cash-base...
Fda quality system regulations knowledge
Iso 14971 risk management expertise
Design verification and validation
The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures

Job Summary

  • The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures.
  • The Design Assurance Engineer will ensure a successful transfer of newly developed product to production, while supporting design phases concept through launch.
  • Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success and includes base salary, cash-based incentives, comprehensive benefits, and 401(k) with company matching.

Matching Summary

The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures.

Salary

Base: $120,450 - $176,660; Bonus/Equity: Cash-based incentive program; Benefits: Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with company match

Skills & Requirements

Must-have

  • FDA Quality System Regulations knowledge
  • ISO 14971 Risk Management expertise
  • Design verification and validation
  • Supplier risk management
  • Statistical methods proficiency
  • Quality lean sigma tools

Nice-to-have

  • Strong collaboration and negotiation skills
  • Excellent technical writing skills
  • Leadership and coaching abilities
  • Excellent verbal and written communication

Key Requirements

  • Bachelor’s Degree in Engineering or related field
  • 7-10 years of experience
  • Master’s Degree preferred
  • Experience with FDA and European regulated medical devices

Work Rights

Not specified

Tailored Resume

Cover Letter