Senior Design Assurance Engineer

CyberJobsHub

Plymouth, MN, United States
Base: $120,450 - $176,660; bonus/equity: cash-base...
Not specified
Fda quality system regulations knowledge
Iso 13485 and medical device directive expertise
Risk management (iso 14971) leadership
Integer is seeking a Senior Design Assurance Engineer in Plymouth, MN, to support new product development in the medical device sector. The ideal candidate will have extensive experience in quality and reliability engineering, particularly within FDA and European regulatory frameworks

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

Match Score: 85

Integer is seeking a Senior Design Assurance Engineer in Plymouth, MN, to support new product development in the medical device sector. The ideal candidate will have extensive experience in quality and reliability engineering, particularly within FDA and European regulatory frameworks.

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 13485 and Medical Device Directive expertise
  • Risk Management (ISO 14971) leadership
  • Design verification and validation expertise
  • Statistical methods proficiency
  • Quality lean sigma tools utilization
  • Supplier risk management

Nice-to-have

  • Strong collaboration and negotiation skills
  • Conflict resolution abilities
  • Team leadership and coaching
  • Excellent technical writing skills
  • Effective communication and presentation skills

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
  • Proficiency in statistical methods such as ANOVA, SPC, DOE
  • Knowledge of medical device sterilization process

Work Rights

Not specified

Tailored Resume

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