Senior Design Assurance Engineer

Integer

$120,450 - $176,660; not specified; comprehensive ...
Iso 14971 risk management
Design controls
Supplier controls
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.
  • Leads Risk Management (ISO 14971) and Usability program activities, leading cross-functional teams in planning, analyses, and mitigations.
  • The company offers a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.

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

$120,450 - $176,660; Not specified; Comprehensive benefits package

Skills & Requirements

Must-have

  • ISO 14971 Risk Management
  • Design Controls
  • Supplier Controls
  • Design Verification and Validation
  • Process Validation

Nice-to-have

  • Customer success focus
  • Innovation and collaboration
  • Respectful interaction
  • Open and honest communication
  • Integrity in actions

Key Requirements

  • Bachelor’s Degree in Engineering or related field
  • 7-10 years of experience
  • Practical knowledge of FDA Quality System Regulations, ISO 13485 and Medical Device Directive
  • Proficiency in statistical methods (ANOVA, SPC, DOE)
  • Proficiency utilizing quality lean sigma tools

Work Rights

Not specified

Tailored Resume

Cover Letter